Art Exhibition – The People Who are Keeping Me Alive

Many months ago one of our PPI Clinical Trials group at Imperial Cancer Research, Rina, presented to us an idea.  Rina was super excited and you could see such animation and fun when she explained what she was thinking of.  Rina was also so clearly passionate about demonstrating that during her care and treatment for cancer she had been looked after by so many staff.  As Rina said we often only talk of our consultant or nurse during treatment but there are in fact so very many others who have looked and continue to look after us.  The receptionist, the phlebotomist, radiographer, radiologist, surgeon, anesthetist, appointment maker, chemo nurse, clinical nurse specialist, research nurse, porter, scientist, cleaner, hospital catering team, etc etc.  In fact Rina was able to name so many not only by title but by first name I, for one, was terrifically impressed!


Rina wanted to honour those who had been keeping her alive.  She wanted to show the world that there were so many more involved than just her surgeon or nurse.  She wanted to demonstrate that they all had names (not just titles) and also that they had passions and loves outside of the environment that she knew them, ie the hospital.

Tonight was the launch party for the exhibition.  A time when all those of us to see the idea become a reality.  For Rina to be able to get her ‘team’ in one location and say “Thank you for keeping me alive”.

Clinfield 2014

The exhibit is kindly sponsored by Cancer Research UK and will be on display at The Cancer Research UK Imperial Centre in South Kensington until the end of November.  If you’re in London, do make time to visit.  More info – here

Because of Rina’s exhibition, Cancer Research UK have launched a campaign on twitter for YOU to nominate your hero.  Who was your hero?  Nominate them using #RinasHeroes and @CR_UK.

Clinfield Conference – speaking!


The Clinfield Conference provides an opportunity for research nurses, allied healthcare professionals and all research practitioners to get together in a formal setting.  The Conference programme is put together with care to provide sessions to share good practice, things that worked and didn’t work, speakers talking about their career development pathway, patient advocates talking about their experience with research and how they can assist the researchers, debates and also invaluable time for networking.

I have previously been invited to attend this Conference twice by Kelly, who also leads our PPI Clinical Trials Group at Cancer Research Imperial.   In April this year I received an email, from Kelly, asking if I would like to do a session, as a patient voice, for either a panel or a debate on the use of social media for recruitment to clinical trials.  Of course, I said ‘yes’, put it in my diary and forgot all about it!

Conference Agenda

09:30-10:00 Registration

10:00-10:10 Welcome Professor Janice Sigsworth

10:10-11:00 Why clinical trials and the people who run them matter. Key Note Speaker: Mr Charles Sabine

11:00-11:15 Inspiring the next generation through student placements.  Mary Harrison

11:15-11:45 Coffee

11:45-12:45 The Great Debate:  The use of social media enhances dissemination and engagement in clinical research.

Chair: Gordon Hill Debaters: Teresa Chinn- We Nurses, Matt Ballentine, Dr Les Gelling- REC Chair, Anna Wallace- Patient Representative

12:45-13:00 Considering a Masters in Research? My experience so far. Stuart Gormley

13:00-14:00 Lunch

14:00-14:25 Stratified Medicine:  the challenges and ethical dilemmas genetic testing brings to research.  Professor Martin Wilkins

14:25-14:45 Can I retweet please? Health research recruitment and the Twittershpere. Professor Heather Skirton

14:45-15:15 Coffee

15:15-15:30  Regret in patients with acute and chronic conditions recruited to stem cell clinical trials Katrine Bavnbek

15:30-15:45  Beyond Research Delivery to Design and Dissemination- Extending the Role of the Research Nurse Caroline French

15:45-16:00 Closing Remarks and Award Presentations Professor Christine Norton and Kelly Gleason

The whole conference was inspiring but none as moving as Charles Sabine’s presentation.


Charles spoke candidly about his career as a TV journalist where he spent many hours and years reporting from war-torn parts of the world.  No doubt an incredible career and something that few of us would be brave enough to do.  But then he spoke about something way braver than his time in journalism.  He had the whole audience hanging on his every word and, at times, wiping a tear away.  Charles’ father was diagnosed with Huntington’s disease (AKA HD).  He watched as his father ‘disappeared’ before his eyes.  From an intelligent, articulate and ‘alive’ man, he became reliant on others for everything.   HD is a progressive and hereditary disorder for which there is currently no cure.  Charles and his brother have had genetic testing and both tested positive.  Charles’ brother, John, an incredible successful lawyer, is now battling this fast moving and progressive disorder.  For the moment, Charles has no signs.

Charles, like so many of us when we are told ‘there is no cure’ ‘there is no research’ or ‘you’re unique’, uses his experience in journalism and as a son, brother and person affected by HD to a different use.  He is now a spokesman for freedom of scientific research, and sufferers of degenerative brain illnesses (including HD).  He has been talking about his experiences at conference such as this, raising awareness, rallying and organising groups of people affected by HD to speak up and get involved.  He spoke of HDBuzz, Huntingdon’s Research News.  He also spoke about The Huntington’s Disease Youth Organisation (HDYO) where younger people diagnosed with HD are able to get together in person, online, via social media to support one another but also to push for changes and research.

Charles’ presentation without any hesitation was moving.  I wasn’t familiar with HD.  I am now.  But what I also see is the impact that a patient voice (albeit one from the tellybox) can have on improving awareness, patient care, support and, the everso needed research.  Charles’ experience with HD is similar to other rare conditions and diseases and what Charles demonstrated was that by using social media, by using our voices we CAN make an impact.  Research may not be within our lifetime nor may it make a difference to our own health but to KNOW that we  have made a difference for future generations and that, particularly in the case of hereditary disease, our children or grand-children will have the benefit of our involvement now.


I felt for Mary Harrison, the next speaker on the podium.  How could anyone possibly follow Charles’ presentation?  She did, brilliantly.

Mary is clearly passionate about encouraging and enthusing the next generation.  About engaging all new students in research so that it becomes part of their ‘everyday’ no matter which medical field they end up in for their career.  Research should be second nature to consider for each and every person, patient and non-patient.  Without research medical advances cannot be made.  Healthcare improved and a better and longer quality of life gained.

It was wonderful to hear some of the initiatives and working methods that have been implemented and that Mary is championing.  I hope that others attending the conference were able to go back to their workplaces and implement similar projects.

10690252_790103731037931_4089365723065417337_nAfter a short coffee break, it was time for the Great Debate: “The use of social media enhances dissemination and engagement in clinical research”.  I was on the stage!  We had four debaters, 2 for the motion and 2 against.  My job was to debate against the motion.  The chair for this session, Gordon Hill, introduced the debate and asked for a show of hands for and against the motion.  There was one lonely hand waving ‘against’.

10687141_790104117704559_3378078328530090806_n10421999_790103884371249_2477100869151685393_nTeresa Chinn, @WeNurses, presented her arguments FOR the use of social media.

Compelling arguments and we could see a great deal of nodding from the audience.

Dr Les Gelling @Leslie_Gelling was first to present his arguments against.1932271_790103911037913_2057804842392007702_n

Again I looked out at the audience and saw nodding and acknowledgement of the points Les raised.

10351655_790103937704577_40107761402128731_nMatt Ballantine @ballantine70 stood next to argue FOR the usual of social media.


1538625_790103957704575_6793728141737878822_nLast to speak was me.  I questioned if you could really engage people with 140 characters and provide enough information for them to make an informed choice.  I queried the use of acronyms to reduce the character size reminding the audience that patients and carers don’t yet know what these acronyms mean.  I was also able to mention ‘Phyllodes’ in my short presentation 3 times… hehehe a room full of researchers have now heard of our rare cancer!

Without a doubt the debate was difficult.  All four speakers are active users of social media and see the value of the medium for dissemination of information.  Les and I had discussed before the debate how it was difficult to sound passionate about  an argument you didn’t believe in.

In the summing up, Les did a wonderful job of putting doubt into the audience’s mind.  About ethics, confidentiality, understanding, interpretation and audience.

1486625_790104004371237_6015179206767551081_nThere were some very interesting questions from the floor and even some examples of where the use of social media had worked already.  Namely when recruiting young mothers to a trial via MumsNet.

Finally a show of hands from the audience to see who was now FOR and AGAINST the motion.  Les and I had won the debate – there was now no longer a lonely arm waving but a large number in agreement with our arguments.

I must admit to despite winning the argument feeling a little disappointed.  I am in favour of the use of social media for dissemination of information.  However what was highlighted in the arguments and questions was that perhaps we’re not quite there yet.  Not everyone feels comfortable with social media.  Not everyone uses it.  We’re not yet au-fait with using social media effectively nor do we know the true impact of using it.  Social media is still in its infancy and as such there is still a great deal to learn.

It should be something that is used for some aspects now.  It is somewhere that we can learn more and engage and encourage people to become active in research.  It is somewhere that can clinical research trials can be advertised or links to recruitment programmes be discussed.

I think the debate was wonderful as it clearly made the audience think more closely about their use of social media.  It will hopefully mean that it can be used as ‘part of’ a recruitment project but with consideration for confidentiality, ethics and understanding.


The afternoon sessions at the conference were fascinating.  It was wonderful to hear from various people about their passion for research, inclusion, consideration of patient side effects and quality of life but mostly about the willingness to share with others their experiences (good and bad).  I know that all those attending this conference will have left with a new understanding of some aspects of research and I’m quite sure many will have been implementing changes or looking at the way they’re currently operating to improve the research landscape.

I’m passionate about research.

It should be part of everyday conversation.

Sadly most of us only think about research when we or a loved one is ill.

Research is also conducted on people who are well with the use of surveys, spit or blood samples.

Research doesn’t have to be invasive or require the taking of medication.

YOUR involvement in research could make a difference in the future.

The Great Debate: Should we use social media to recruit patients in clinical research?

Eeek the Agenda has been published for the annual Clinfield Conference for Clinical Research Staff.

Guess who’s speaking and part of the panel debate? Meeee….

“11:45-13:00 The Great Debate: Should we use social media to recruit patients in clinical research?
Chair: Gordon Hill Debaters: Teresa Chinn- We Nurses, Anna Wallace- patient representative, Les Gelling- Ethics Chair”

As always it will give me the ability to mention ‘Phyllodes’ and this occasion to a room full of people at the coalface of clinical research.

As you will all know from this website social media has played a huge part in my finding other people diagnosed with Phyllodes; sharing experiences and supporting one another; researching medical/scientific papers and sharing them with the group; discovering clinical trials around the world and again sharing them with the group; and so much more.

I know that when we’ve discussed clinical trials and research within social media, the thirst for knowledge, how to sign up and get involved and interest in any results and findings from group members is enormous.

Using social media as a way to recruit patients into clinical research is a no-brainer.  It should also be used to educate and inform patients on what research is; what and how you could be involved; why it’s important for medical advancement for you and others; etc.

My ‘journey’ would have been a very different one had social media not played a part.

I’d love to hear your comments.

PPI Group – Imperial/Cancer Research – Meeting

A fascinating meeting this evening of the Patient and Public Involvement Group from Imperial College and Cancer Research.

We meet regularly however often we discuss aspects that I’m unable to share with you so I don’t post a blog entry about every meeting.  However some of the tweets/facebook posts about upcoming events or opinion may be posted from Living Beyond Diagnosis accounts.

Tonight’s meeting was slightly different to our usual discussions.  In that many of the agenda items related to artistic and creative projects that it is hoped will support, aid and influence both patients and the public.

I am unable to go into the finer detail but wanted to share a little about the items and ask for your feedback.

Artwork in hospitals and cancer clinics.  An artist has been commissioned to produce some artwork for display in a very busy hospital cancer clinic.  Tonight he was able to share with us a few of his ideas of what he would like to produce and also to hear our feedback and comments on the proposed work.  His medium is ceramics and his aim is for the artwork to be uplifting for patients, intriguing and engaging for those who may visit the clinic often and perhaps to also be further dimensional to include some more medical references and in particular research and cells.

No mean feat ahead of this chap.

What a wonderful project… for him to create and of course for others to enjoy.

The discussions this evening were varied.  Some were very much for it being engaging and uplifting.  Some felt that if it had medical references to research and cells it may be too much in this clinic but others thought it may bring about discussion and hope.  We discussed where it should be placed.. or perhaps could it transcend both the reception desk and surrounding walls?  Perhaps to include some clever lighting?  There are many considerations and much planning to also ensure that no matter where you sit or walk within the clinic you can enjoy the artwork.

What would be your considerations?

Video Project.  We were presented with a video project that has been taking place over the past 6 months.  Video cameras were given to 9 women who had been diagnosed with breast cancer (some with secondary breast cancer).  Each women was asked simply to record whatever they liked.  Some did a ‘talking heads’ approach of short interviews to camera; others were determined to show their families and life living WITH cancer; most of them showed bad times as well as the good; living with side effects; what the treatment and drug regime was like; and so much more.

The videos have been sensitively edited (with each of the women involved) and the task of how best to use the honest and open footage to educate the public and also support and inform others diagnosed.

The aim is that it will become part of an art installation where each video is played continuously on 9 walls of a gallery.  Thereby giving the ‘viewer’ the opportunity to watch all or part of each journey.

It is also hoped to edit the footage (approximately 2hrs for each lady) down to a documentary length and to be able to get it onto the TV.

We also discussed the possibility of some of it being used for the training of people working with cancer patients.  Medical professionals but also HR/employers.  Perhaps in a similar way to the GP Training film that I was involved in that is now part of the London Deanery GP training.

Where else do you think this could be used?

I suggested that in addition to the current footage perhaps another video project might be looking at the 360* surrounding the diagnosed.  For example taking a point in time of the diagnosis (perhaps being told of cancer, the start of treatment, surgery dates etc) and asking the diagnosed to tell what that moment was like as well as their colleague, husband/wife, child, parent, neighbour, friend etc etc.  To demonstrate that cancer affects much more than the individual and allowing others to understand.

Portrait Project.  A fascinating project created and considered by a lady herself diagnosed with secondary breast cancer and recently told that she is now in palliative stages.  Her background is in visual media and she would like to share her journey through photographs.  HOWEVER not of herself but highlighting the wonderful team of medical professionals that have been part of her journey, have been keeping her alive and indeed for whom she is truly grateful.  She would like to say thank you and for others to know that a cancer patient’s journey is filled with teams of professionals who work together for the best outcome.

She has put together a team of photographers, videographers, editors and other talented people who will be responsible for capturing each and everyone who’s been involved in ‘keeping her alive’.  From the nurses, breast consultant, sarcoma consultant, oncologist, heart specialist, plastic surgeon, wig fitter, receptionist, cleaner, anesthetist etc etc.  They are asked (and with her guidance) that each portrait will show the person behind the white coat as well as acknowledge the work they have done.

It is aimed that this portrait project will be finished and on display in SW London in September of this year.

Tissue Collection.  At this point, I can’t tell you everything about this agenda item.  However I would like your opinion please.

A great deal of cancer research is carried out on tissue samples taken from patients via a biopsy or surgical excision.  Sadly not everyone knows how to donate tissue to research projects and, historically, consultants are concerned about having discussions about research with patients so this may be overlooked.

My question to you is at what point and with whom do you think you should have a discussion about tissue collection for research purposes?  Was it discussed with you?  How did you feel about it?

Are you aware that cancer cells change during a cancer ‘journey’ and particularly if it spreads to other parts of the body.  There is therefore huge value in tissue samples being examined from each part of the body affected and indeed researchers feel that this information will help guide to the best outcome for individual treatment.

Another taboo that needs to also be overcome (in my opinion) is that of tissue donation after death.  Researchers again have huge value in looking at the tissue of a deceased patient.  If they are able to compare the tissue with that taken from a primary tumour and again any secondary tumours, they believe this may also aid them in understanding cancer development and further treatments.

Would you give your specific consent to tissue sample being taken after you death?  When and how do you think it should be discussed?

Breast Cancer Lecture Series.  There next in the series – “The Secondary Breast Clinical Nurse Specialist: her role in breast cancer patient care.  6-7pm 15th July at Maggie’s Centre, Charing Cross Hospital.

These lectures are in an informal setting and after the talk you are invited, and encouraged, to ask questions of the speaker.  Please do pass on the invitation to others.  If you’re interested in attending please email Kelly Gleason as places are limited to approximately 20 people.

I’d love to hear from you about any of the points above.

Risk Assessment: Breast Cancer, Prediction and Screening

Progress Educational Trust are hosting a series of events relating specifically to breast cancer. The variety of the talks cover genetics, gene testing, prediction, screening and risk.

Tonight’s free talk is being hosted at UCLH in North London and supported by Wellcome Trust. I was told about this event by a couple of people, one of whom had heard of it from the US and suggested I attend.

I was particularly pleased with the variety of speakers for tonight’s event. A spectrum of experiences and also of opinion.

Event Title: Risk Assessment: Breast Cancer, Prediction and Screening

Introductions from the organisers (Sarah Norcross – Director of Progress Educational Trust) and the Chair (Dr Ann Robinson – North London GP and Health columnist for the Guardian)
Wendy Watson (Founder and Director of the National Hereditary Breast Cancer Helpline)
Paul Serhal (Founder and medical Director of the Centre for Reproductive and Genetic Health)
Professor Stephen Duffy (Professor of Cancer Screening at Queen Mary University of London’s Centre for Cancer Prevention, and Director of the Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis)
Professor Klim McPherson (Professor of Public Health Epidemiology at the University of Oxford’s Nuffield Department of Obstetrics and Gynaecology)

Each speaker only spoke for 10 minutes and this was then followed by an extensive question and answer session.

Wendy Watson spoke about her own journey. She was one of the first women in the UK to undergo a risk-reducing double mastectomy. Her own research led her to make and insist up on this surgical decision. She then sought to set up an advice line and raise awareness for others facing a similar decision. She has published her book “I’m still standing: My Fight Against Hereditary Breast Cancer”.

Wendy told us that 1 in 200 have genetic damage which may imply a higher risk of breast cancer. Wendy believes that more should be done and available on the NHS for women AND men to discover more about their genes and if any mutations have occurred. If you are concerned about a hereditary risk of breast cancer, her organisation, National Hereditary Breast Cancer Helpline offer support, advice and in some instances, funding for screening.

Our next speaker Paul Serhal. Paul spoke passionately about his field. He was responsible for the UK’s first baby born following pre-implantation genetic diagnosis for BRCA1 mutations.

Pre-implantation genetic diagnosis (PGD) is a technique that enables people with a specific inherited condition in their family to avoid passing it on to their children. It involves checking the genes of embryos created through IVF for this genetic condition. More information can be found at Human Fertilisation Embryology Authority.

Paul was passionate about the importance of his work and what it means to the people he assists.  I was so pleased to hear also that they currently have no waiting time, have some funding arranged for suitable patients and can offer 3 cycles to each couple.  I know of people who have the BRCA mutation and have considered NOT having children because of it. This work would assist many.

The third speaker was Professor Stephen Duffy. Prof Duffy was part of the original team who adapted the Swedish two-country trial of breast cancer screening on which the UK’s national breast screening programme was based. He remains an advocate of our screening programme and is often quoted at times when people say that the screening has led to over diagnosis of breast cancer in the UK. One such quote “In particular, it is good news that lives saved by screening outweigh over-diagnosed cases by a factor of two to one“.

He spoke about the difficulties of screening for women with dense breast tissue. This is often raised when discussing reducing the screening age as younger women tend to have denser breast tissue. Prof Duffy said that often there is less lead time to diagnose breast cancer due to the difficulties reading mammogram results of dense breast tissue.

I was delighted to see that he has also just been appointed as Senior Investigator by the National Institute for Health Research

Our final speaker was Klim McPherson. Klim focusses his research on epidemiological methods and women’s health. He spoke about the factors that contribute to breast cancer. To give you some idea, I found this quote from the BMJ “Klim McPherson is the man least likely to accept an invitation to lunch at McDonald’s

His research has led him to look at and compare the US to the UK. He identified that the US certainly were far more radical with their surgery and treatments – however it wasn’t clear how much of this may be due to ‘insurance’ factors but felt not always necessary.

He was pleased to note that although breast cancer may be on the rise for being identified and diagnosed it was now much rarer to die FROM breast cancer.

So how can we avoid getting it?

  • We are getting periods at a younger age and having children at an older age.
  • He found that if you had your first period at the age of 11, you were 3 times more likely to get breast cancer than a girl who started their period of age 14.
  • There is a higher risk of breast cancer in women who have taken the pill or HRT.
  • 5 years of HRT doubles the risk of breast cancer.
  • Obesity post-menopausal makes you at much higher risk of breast cancer.

There’s a 20% reduction in breast cancer when in the breast screening programme i.e. every three years. It is imperative that people attend their screening when invited.


There was then a long period for questions from the audience to the panel. As this was a free to attend event open to all, I was pleased to see a good variety of attendees and hence with the questions raised, I’ve stated who the questioner was.

Q1 Scientist – What’s the extent of genetics, epidemiology & screening connection?
KM – Yes they are connected. There is an Integrated Pathway (which is new) that is assisting with the integration of these three areas in determining healthcare.
Q2 Dr – If money was NOT a factor, what would a perfect screening programme look like for breast cancer?
SD – About right with the current screening programme i.e. 3 yearly mammograms. There is often talk of MRIs being better however patients don’t like MRIs and although they may be marginally more effective experience tells them that they produce more false positives so may lead to unnecessary surgery or treatment. Angular mammograms where using architectural distortion produces measurements of angular distribution i.e. slices of the breast may be more accurate but are complicated to read and produce.
Q3 Patient advocate – Spoke about the importance of trials, clinical and surgical. Asked what could be done to ensure more patient involvement and also of the recent DCIS trial.
Q4 Patient – What is offered to ladies under the age of 30 who have been tested positive for BRCA mutations by way of screening? Mammograms are not offered nor the option of going onto the normal breast screening programme.
SD – He reiterated that most screening is ‘pointless’ for people under the age of 30 due to the denseness of breast tissue.
Q5 Journalist from Pink Ribbon Magazine – To Paul asking more about the PGD programme and requesting information.
Q6(1) Clinical Geneticist – If we delayed puberty then this might/would reduce cancer… why can’t we?
There was much discussion about the ethics around this and although there was a consensus that it may reduce cancer, would it be ethical to do so?
Q6(2) – If each child was tested for BRCA at birth or perhaps a mutated bowel gene and found positive… could we delay their puberty knowing this may reduce their long term risk of cancer?
Again much the same discussion. Yes it may help but would it be ethical? What other implications may this have upon the person emotionally and psychologically?
Q7 Genetic counsellor – How many genetic counsellors are there in the UK and where are they? It was felt that many genetic scientists went on to become genetic counsellors and nurses in this field. However nobody was sure if there was a directory of genetic counsellors in the UK.
Q8 Patient – Why is breast cancer in younger women rising? What are the risk factors and how can people avoid them?
KM – He reiterated earlier periods and later pregnancy. He also discussed the increase in our use of plastic based products from an early life. Makeup, deodorant etc etc often contain oestrogen like products in the plastic and we’re putting this daily onto our skins from an early age.

There are two final events in the series. Sadly I’m unable to attend but please do go along ‘Risk Management: Breast Cancer, Business and Patents‘ on Thursday 5 June, and a concluding event on Thursday 3 July.

Thank you to the Wellcome Trust for supporting this series of events and UCLH for hosting these events by the Progress Educational Trust.

Building Careers in Clinical Research Conference

This conference is held annually for nurses and health care professionals to understand about clinical research as part of their career path, network and share ideas and good practice.

Conference Agenda – Clinfield Conference

Clinical research nurses are historically an under recognised group within the healthcare setting.  However their work is invaluable to advancing medical research and patient understanding to available treatments.  The skills of clinical research nurses are so often under-utilised within mainstream clinical practice and the research agenda but offer so much.   One the main discussions at the conference therefore is to look at the broader agenda and look at where we can each promote the invaluable work that the clinical teams do.

My invitation to participate in the conference came to me because of my involvement as a patient advocate/representative with Imperial College Hospital.

Throughout the day’s conference there was an overwhelming enthusiasm for spreading the word about clinical research.  For better understanding about what clinical research actually is and what is available at the bedside together with what is being developed in the lab.

Certainly I have been aware that there isn’t enough information nor knowledge available to patients nor also a practical matter of fact guidance to what clinical research truly is.  As patients we there is a need (in most of us) to know that research is being undertaken to advance medical care.  To know that there are changes that may benefit us or those who travel the road behind us.  To know that involvement in a trial will not leave us like the Northwick Park ‘Elephant Man’ drug trial.  To know that participation in research may mean simply completing a survey of questions every few months or having your bloods analysed regularly.  It’s not always about a taking a new drug!

What I discovered from this conference was that it wasn’t only the patients who didn’t fully understand clinical research – it’s also the doctors and nurses in clinical settings.  I guess it’s understandable that a GP might not be able to keep up with all the ‘new’ research.  Less understandable for doctors and nurses in a hospital environment but still possible.

This is why it’s critical that ‘clinical research’ is something that is taught in medical school as progress.  That there is an easily accessible, searchable and functional database of trials available to all.  That the trials in the database are up to date and have contact details of who’s in charge and how to participate.

It’s also critical that there are trained clinical research staff available for consultation with patients and colleagues alike.  These staff members to have a voice at MDT settings so that all staff are aware of their role and expertise.  They should also span the gaps between primary and secondary health care settings.  Referrals of patients are sent to them to have research explained fully to them and how they may participate.  They should also, with training, be able to dispel any myths about elephant man etc and to encourage the positive impact of clinical research.

In addition the role of a clinical nurse specialist doesn’t have to be a full-time role.  There were  a number of speakers who told us of how they had embraced their clinical role in addition to research.  As a midwife, as a nurse, as a lab clinician… perhaps this is one of the best solutions so that they’re able to bring both practical and research experience to each case.

An excellent conference and certainly there was a great deal discussed for me to consider in my many networks and patient advocate involvement roles.  Below are a few bullet points:

  • Historically clinical research has been under recognised in healthcare.
  • Clinical research skills are under-utilised in main stream clinical practice and research agenda.
  • Need to look at a broader agenda.
  • Need to promote the invaluable work that the clinical teams do.
  • More multi-professional education and training needs
  • Research, translation and innovation
  • Through research we bring some certainty in an uncertain NHS world
  • A larger impact on health is from ‘public health’ rather than ‘medical health’ – need to re-balance
  • Gaps between primary and secondary health care.  Closer integrated working practices are needed.  New ‘Pioneer Program’
  • Targets are not the same as outcomes
  • Patient Centred culture
  • RCP – Circle of Patient Centred Care
  • RCP – Future Hospital Commission 2013 diagram
  • Competencies and appraisals for research nurses should change and be updated in methodology
  • We don’t do enough to raise awareness of clinical trials
  • Need more clinical research training provided to clinicians so they’re able to speak with patients
  • More accurate information on hospital trust websites and other websites i.e. charities, local authorities etc
  • PALS should receive training too
  • Everyone should be aware of ‘We do clinical research
  • National Institute for Health Research Clinical Trials
  • Involvement in research benefits patients but also hospital trusts – financially and with reputation
  • Managers and senior colleagues should support staff in training and research recruitment practices
  • Work with the media and charities to send ‘good messages’ about research not just dramatic headlines
  • Other healthcare professionals including pharmacies should be involved and aware of clinical research.
  • Always feedback results (good and bad), send thank you’s to those involved and offer further involvement
  • What do clinical nurses do?
  • Read Kerry Stott’s blogs about clinical trials
  • We Nurses‘ website  and also twitter @wenurses

“To find your mission in life,” author Frederic Buechner is quoted as saying, “is to discover the intersection between your heart’s deep gladness and the world’s deep hunger.”

Research changed my life

“If we are serious about patient choice and patients having a partnership with clinicans, then we have to be serious about raising patient awareness of clinical research opportunities.”

Sarcoma SPAEN Conference – Day 3


Derek Stewart, OBE Associate Director for Involvement at National Institute for Health Research – Clinical Research Network, England
Public Involvement in clinical research
Improving Research – Involving patients, carers and the public

Whilst you have your voices, use them and use them to effect.”

I’m not a researcher, a doctor, etc but that shouldn’t stop us getting involved in research. We don’t need to know what they do but we need to sometimes tell them what we see. It is our job to bring the professionals back to earth. Never think you need knowledge, a university degree, particular skills… all of us can get involved in research.

From patient … to advocate, activist, ambassador and associate

  • Participation – taking part in a trial
  • Engagement – I get a newsletter, find out what’s going on, I’m asked to go to meetings.
  • In the middle – Patient Involvement. Where we actually hold hands with each other working together as clinicians, researchers and patients.

Why is it important for SPAEN?
Your Patient and Carer EXPERIENCE is of VALUE
Gold dust to researcher… they can work on it forever more. YOU have knowledge.

Did you know about cancer before you got it?

Your knowledge is fantastic.
You still have questions that are unanswered. How do I get those answers? That’s research.

Our bodies. When they ask us to get involved. It’s our bodies. We should have a say in that. It is our DNA what happens in it, what happens in genetics we should be able to speak about.

It’s our money £££$$$$. The charities are not the funders of research… it’s our money given to them directly or via taxes. Never forget it.

How can we make a difference?

Inform -> Form -> Influence

Inform – your experience can help. Tell them what happened but remember that sometimes researchers live in a little bubble and think that their idea is the best ever. They need the experience to understand… that’s us. We can work with them to learn and influence to improve the system and the policies.

Consultation -> Partnership -> Patient centred culture (bring fresh air to open the doors and windows)

Clinical Research Network in England. Supports the infrastructure in England Funding an integrated Clinical Research Network.

Supports Involvement of Patients, Carers and Public involvement
£3m put into it. 1,200 patients.

It is 70 days from accepting the trial to the first patient involvement.

A Movement for Change
Fight for Sarcoma, GIST and Desmoid. Bang that drum at all times.

  • But on the bigger picture. We’re all aiming to create better research. Based on our experience ad patient outcomes as a result.
  • We are all wanting to see simpler and more effective systems that get research on to the books.
  • We should all be making sure there is clearer access to research studies. (Hospitals claiming they’re a world leader in research but reception didn’t know… no leaflets etc… On the website ‘get involved in research’ it says how to donate body to research.
  • Improved recruitment. If we’ve not helped with the leaflets, what time, etc Think about what’s needed to improve the recruitment process.
  • Open access for results. We need ALL trial results to be published. They cannot hide the results.
  • Speedier application. Good research needs to be applied not sit on a shelf somewhere. The clinician (ALL) should be up to date and giving us the best and up to date information available based on the research. Always ask your consultant – ‘What’s the research on this?’ Is this the latest research?’
  • Better patient outcomes. Sometimes research is done for clever researchers but we need to ask what is the outcome and what is the difference that this is going to make.
  • Satisfactory experience. Do we ask people what their experience was like when they participated in trials?

Are we making a difference?

Action on Access booklet
Impact of Patient, Carer and Public Involvement in Cancer Research – NCIN leaflet.
Sarcoma UK’s Research Advisory Committee

  • Getting Involved
  • Understand the context. No point in going into a meeting with a researcher – are they looking at recruitment, funding or what?
  • Be clear about the goal and the purpose. Don’t expect an answer… Goal and Objective Settings. If you ask researchers you often get the answer – I’ve just been told to involve patients. Discuss.
  • What happened? What was the impact? If we don’t’ have a goal we won’t know if we’ve achieved it.
  • What was the benefit? (Benefit may be negative – feed it back to them..)

Context – purpose – impact and benefit.

What can you do? 20th May International Clinical Trials Day.
Let’s have you doing something. SPAEN members… promote it. Raise the profile of research.
Simon Denegri’s lay review

Involvement for Access
UK Clinical trials database 

When we first got involved the British Medical Journal wrote an article about patients getting involved in research about patients being aliens at the table.

View from the Top
Dame Sally Davies – “No matter how complicated the research, or how brilliant the researcher, patients and the public always offer unique, invaluable insights. Their advice when designing, implementing and evaluating research invariably makes studies more effective, more credible and often more cost efficient as well.

Signpost people to consent form, finding out information, exploring impact. Learn the language of trials. Do not give up…

When patients are present, we make a difference.

Q&A Session
Q – we are trying to involve Europe wide in clinical trials. One more problem is that European Clinical Trials Register is not suitable for giving information to patients as it’s not accurate or complete.
A – It’s why we need to be at the table and keep doing this. Danger in Europe from some drug companies fighting against open access. We mustn’t do solely fight for one cancer against another disease… we keep on.

Q – Inspiring presentation. Positive energy thank you. How do I respond to my Dr that once I have mentioned that I am participating in a patient group, they close all the doors and windows?
A – Only tip I can give you is try to find another Dr in the area, another clinician, another group…. Because when your Dr hears you are talking to them, they often think ‘I should be doing that too’. Often Derek asks ‘what are the problems you’re facing and how can I help?’. Ask them about why they get involved, what their passions are etc… build a rapport.

Q – We have the opportunity to create a patient group in bone sarcomas. Do you have the experience and wish to be involved?

Q – What would you say are the three main points to get involved?
A –
– Knock on the door.. if you can’t get through the door, go through the window.
– Never feel that you haven’t got a right to be there.
– Keep a simple diary, a few notes about what it felt like not knowing. We need to remember what it’s like for someone starting out. “I walked ½ way round the lake but was too tired, so walked all the way back”. As you know as you learn you improve… remember what it’s like at the start.


Markus Wartenberg, SPAEN, Germany
Practical experiences and examples from patient organisations

Patients Involvement in Cancer Clinical Research.

When we look to our experience as patient groups.

  • Majority of patients. No or less knowledge about trials or experience. Perhaps about experiments not trials.
  • Very often we see we have no transparency about access. Where do we find Clinical trials in rare cancers?
  • Access and specifically in rare cancers. Access beyond borders in EU.
  • Access in the direction of losing patients who are not being referred to trials because doctors are losing the patients.
  • Practical issues – schedule? Distances? Costs for the patients.
  • Informed consent. Very often a medical legal wording that is too much to understand for patients.
  • Some patients are not aware they are on a clinical trial!
  • Is the right trial centre the real experts?
  • Sensitive topics like placebo trials in cancer.

Cancer patients 6-12% of cancer patients are participating in clinical trials.

  • Public image vs guinea pigs
  • Barriers to clinical trial accrual/recruitment

This leads to delay in knowledge/innovations, slower progress etc.

Trials and Endpoints?

  • Patients don’t care about ‘endpoints’
  • Their personal status/pathway/options -> important whether they ‘hope for/expect a
    • Cure
    • Stabilisation of the disease
    • Slow progressing disease
  • Important
    • Expert care in rare caners (centres of excellence)
    • Multi-model approach
    • Drugs – resection – radiation – clinical trials

Often it’s a ‘game’ against time…

Trials and Treatments?

  • Critical – how close are trials/trial results to daily practice?
  • Difficult:
    • Meaningful?
    • What drugs can deliver and what we need?
    • How to measure an innovation/a breakthrough?
    • What is value for money?
    • Target therapies – how to define progression?
    • Do we need more ‘me to drugs”?
  • Targeted therapies – Belittlement of the side effects
  • Quality of life is a very individual topic
  • Individual and ethical
  • Very critical – if treatments are/would be available but are not reimbursed.

Big issue at the moment is we need future options. We need better treatments for the future. But at the moment we also see that we are not able to get the best out the therapy. We need innovations but also need to be involved with the industry and experts to get the best out of the treatments at the moment.

Each patient is unique. There is no THE patient. The obvious differences, gender, age, ethnicity etc but so much more!

Patients who are going into clinical trials. They have an emotional overload as they enter the trials. Fear, shock, hope life death, new territory, confused, depression, anger, need support, options expectations.

Patients have physical aspects: Family commitments, work commitments, side effects, job career, fatigue etc.

Cognitive Aspects; regarding cancer but also for the trials. A new area to learn about.

What’s the role of patient organisations in clinical trials:

  • Information, knowledge, education, inclusion criteria.
  • Inform about background of clinical trials.
  • We can communicate as a patient organisation about available and upcoming trials. Work closely with the medical experts to find out, seek information and work ‘with’.
  • Making trial issues more understandable. Our job to interpret.
  • Supporting recruitment in specifically rare cancer sub-types.
  • Informed consent
  • Aspects of quality of life
  • Dissemination of the results… positive and negative results.
  • Involvement at the design stage. Work together on the issues for the future.

Dialogue with the Customers!

Patients are the customer… previously it was always the doctor… needs are changing

Partnership: Translate From/To The Patient/Customer
Physicians/Researchers <–> Patient Group <–> Researching Industry

Other players in the room – research organisations, regulators, HTA, payers etc.

Patients/Patient advocacy groups have a lot to offer

  • A common patient voice
  • Patient advocacy groups can argue in a way – experts/pharma can’t
  • Motivation to be involved
  • Needs overall
  • Expert patients
  • Etc
  • Etc

Clinical Trials’ offer some collaborate fields
Information access, design/quality and recruitment.

INVOLVE: Challenges

  • The general challenge is not specific enough for rarer cancers
  • Current trials system vs practice
  • Pharma/ experts often have no experience why and how.
  • EU trials directive – legal, confidentiality, regulatory aspects etc.
  • Involvement as early as possible. Not as troubleshooters but from the beginning.
  • Public media opinion. Collaboration is vital.
  • Patient organisations. How to identify patient organisations who are interested, prepared or willing to be involved in trials. Perhaps knowledge.
  • Patient organisations as a professional behaviours. Set rules with industry and behave!
  • We need to go back from talking more to action. Are there pilot projects to learn from.

INVOLVE: Solutions

  • How can we get the best out of our current therapies? Looking at them in practice and work out what to get out of them and improve.
  • New mindset: Patient centric research = Collaboration. Not lip service!
  • Awareness. Bring the topic to policy, healthcare, regulations and the public. Sometimes we need to seek it out other times people will come to us.
  • Working in initiative s for rarer cancers.
  • Working through a better approach for the informed consent EORTC.
  • Intense discussions with our industry colleagues. Getting feedback following completion of a clinical trial… this surely would improve the next one!
  • Training of patient organisations. Understanding cancer clinical research.
  • Medical advisory boards – we need to be involved in a collaborative way in each of these boards for the whole process and have the opportunity to talk to the regulators
  • Look at pilot projects.




Markus Wartenberg, SPAEN, German and Lindsey Bennister, Sarcoma UK
Lecture: The basics of strategic planning and practical experiences from a patient group

Strategic planning is an important part of business skills for patient groups. Idea of session is introduction to the topic…

Questions to consider:

  • Is your group thinking/planning strategically
  • Are you creating strategies from a share vision
  • DO you learn from the past and gather information from and about the external environment
  • Do you have immediate measurable goals in place
  • Are individuals or the boards (teams) accountable to plan
  • Is the organisation creative and flexible
  • Does it recognise, reward and institutionalise positive change.

What about shared vision?
Often people have a difference expectation and view of what is needed or required. You need to find a common shared vision.

A lot of areas in modern life are using ‘strategies’

  • marketing strategy
  • politics
  • elections
  • survival strategy
  • military
  • etc

What about patient organisations and non-profit organisations… makes sense to use strategies.

What is a strategy?

  • A method of plan chosen to bring about a desired future, such as achievement of a goal or solution to a problem.
  • The art and science of planning and marshalling resources for their most efficient and effective use. The team is derived from the Greek word of generalship or leading an army.

Your team! Your goal! Your proceeding? What Questions? How do you do it?

  • Setting part goal posts, markers to get there.
  • What materials do I need? What resources, tools, people?
  • Sharing responsibilities amongst the team members
  • Assuming responsibility as a team member.
  • What experience does the team have?
  • What conditions, environment etc influence your planning?

We have to think about the process and plan. Discuss and build up a strategy and planning process to get there.

What is Strategic Planning?
A systematic process of envisioning a desired future, and translating this vision into roadly defined goals or objectives and a sequence of steps to achieve them.
A systematic approach through which an organisation agrees on the priorities that are essential to its mission and responsive to its environment.
Future/Vision Mission

What is strategic planning NOT…

  • A prediction for the future
  • A smooth, predictable, linear process
  • A substitute for judgement of leadership.

Hope is NOT a strategy.

Benefits of Strategic Planning.

  • Defines mission, vision and values
  • Establishes realistic coals, objectives and strategies
  • Ensures effective use of resources
  • Provides base to measure progress – need to assess value and feedback
  • Develops consensus on future direction
  • Builds stronger teams. A lot of people coming together motivated to do things but are they doing things in the right direction and utilising their skills and strengths.
  • Solves major problems.

Some thoughts for the process

  • Strategic planning involves choosing the highest priority achievements over the period of 3-5 years.
  • What is the strategy to achieve goals.
  • Strategic planning builds commitment to the vision.
  • Important for all levels of the organisation to be involved.
  • A strategic planning committee
  • Outside consultant/facilitator to facilitate conversations, capture external interviews, move the process along or to maybe draft the final plan.
  • In the end, Plan must be owned by the board/staff in order to move it successfully and strategically into the future….

First activity:

  • To assess the current situation and review the relevance of the mission and programs
  • Developing a ‘plan for the plan’ ie this means that if this is a big organisation how will you develop and implement the plan.
  • What is the outcome of the strategic process?
  • What is the time frame?
  • Strategic planning committees composition. Full board members, staff involvement and perhaps an external facilitator?
  • Thinking, collective experience, external and internal research.

Second activity:

  • Summarise the organisational history
  • What has been accomplished and what has NOT been accomplished between the plans.
  • Collecting data and information to make decision.

Book – strategic planning for non-profit orgs

The big 5 for strategic planning:

  • Mission
    • Why does the organisation exist?
    • What is the reason for being?
  • Vision
    • How will your community be changed and made better by what you have done?
    • What is your organisations vision of excellence
  • Value/Beliefs
    • What core principles should guide your organisation in the present and into the future?
  • Goals
    • SMART goals. These are outcome statements
    • Strategies
    • How are you going to meet the goals?

Remember if strategies get too detailed, you are moving away fro m strategic planning and into annual operational planning.

  • Swot – Analysis

What are strengths and weaknesses of organisation. Opportunities, threats etc facing us. This will help with key priorities and process.

Strengths and weaknesses

  • How is your organisation positioned?
  • What are the internal challenges?
  • What are the areas where the organisation shines?
  • Organisation reputation and history
  • Weaknesses such as capacity, funding, infrastructure etc

Resources or strengths that help us to accomplish our mission or mandate or create value for our members (and their patients).
Internal weaknesses are deficiencies in resources or capabilities that hinder us to accomplish our mission or mandate or create value for our members (and their patients).

Opportunities and threats
These are the external factors to the organisation.
Are there new programme areas where you should be new, new funding, community collaborations, regulations, government, economy dependencies etc.

External opportunities are primarily outside factors or situations that we can take advance of to better fulfil our mission or mandate or create.
External threats or challenges

SWOT and other tools
Identify the current environment and will inform your plan. You need to understand what is going on with your environment otherwise you will l have problems about reaching the goal and implementing the strategy.

Screen external relations. Who are the people the organisation are working with? Medical experts, Industry, payers, regulators etc.

What are the main stakeholders the organisation is dealing with. What are their roles, influences, interests, expectations? Are they target groups/audiences for future actions?

But also collection of available data? Do you know everything, have information on target groups, how do they behave etc. About environment and perhaps legal influencers in anyway. Do you know what the needs and expectation of your patients and carers really are?

To complete ‘your picture’ you can also initiate surveys, interviews focus groups etc.

All required to build your strategy for the future.

Putting Patients at the Centre of Healthcare – Strategic Plan 2010-2014 – iAPO

Measurable Activities…


Lindsey Bennister, Sarcoma UK
Transforming the landscape for sarcoma
Sarcoma UK’s Goals and Strategy 2014-2020

If you don’t know what you’re going to do, you can’t know that you’ve made an impact

Lindsay summarised further the importance of planning and strategising that Markus had referred to in his presentation.

Sarcoma SPAEN Conference – Day 1

This is the third year I’ve attended the SPAEN conference. The three days are always action packed, exhausting, thought provoking and inspirational. The delegates attending are from throughout Europe and most of whom have a personal interest in improving the cancer landscape. There are a great many organisations represented and crossing borders, sharing knowledge, experience and information. Importantly working collaboratively on projects, without ego or personal gain. There’s a great deal that charities and businesses alike could learn from this group!

This blog entry is taken from my extensive notes at the conference and I hope will be useful to many. I am quite sure that SPAEN will soon post their own conference report on their website so please be sure to check back.


The Opening Welcome was given jointly by Roger Wilson and Markus Wartenberg

It is a testament to the organisation that this is the fourth year this conference has taken place and membership, interest and outcomes continue to grow. Despite being a European conference we have this year also attendee representatives from USA, China and Australia. Their aim of attending is to understand how a patient group like SPAEN operates, listen to stories and examples from attendees and take back these learnings to their own countries.


Raz Dewji, Director – Clinical Scientist, GlaxoSmithKline Oncology Global Medical Affairs, UK
GSK Europe welcomes SPAEN to UK London as the main conference sponsor

“A personal perspective on the impact the ‘Patients Voice’ in drug development”

A journey that has been incredibly emotional. I’ve learnt how important it is to understand and hear what patients are asking for. Hopefully some of the work that we are doing and other companies are doing is now reflecting the voice that you collectively and as individuals have been delivering at different levels of the few years that we have known each other. I feel very humbled.

A little bit about GSK
GSK is a science led global healthcare company researches and develops innovative medicines, vaccines and consumer healthcare products.

Mission statement – do more feel better and live longer.

A lot of you have contributed in some shape or form to the journey I’ve had in the past 7 years and hopefully able to share some of those insights with you.

Less than 10% of patients with rare diseases are ‘treated’ on a global basis.

GSK concentrating a team on 200 different rare diseases.

Patient centric medicine is an area that is becoming much more focussed and a growing need to understand the patient.

Partnerships between organisations like GSK (Pharma) and patient advocacy groups are critical to bring new treatment options to those who are in need of them. GSK is very proud to be a long-term supporter of SPAEN.

GSK – Focus on the Patient Initiative

  • Post approval Disease Awareness. Once we have a new medicine approved we then work externally to raise the awareness for the disease.
  • Simplification of the information consent form and process (for clinical trials). Really important to try to get some of those documents into a manageable form where patients feel comfortable and the information they are provided with is appropriate not full of legal jargon.
  • Engagement with patients and physicians at different levels. Clinical trial space – to understand the trial and get feedback. How has a trial been for patients? What was your experience?
  • Treatment adherence initiatives. Helping patients to take medications appropriately. Increasing focus on developing oral medications rather than intravenously… however there can be challenges for side effects and also getting patients to remember to take the medication.
  • Working with the patient support groups.

Post approval Disease Awareness
GSK took on an advertisement raising awareness to physicians to what a challenging disease Soft Tissue Sarcoma is – Raising Awareness of a Challenging Disease advertisement.

My first encounter with sarcoma was in 1991…
At the time I was working as ‘study monitor’ based in Brussels doing a lot of work in different oncology drugs.
I was working with a patient and realised that she had the same date of birth as my brother. It still gives him quite a jolt of reality recalling the challenge in these phase 1 trials. These are usually in older patients except often in sarcoma patients who tend to be younger. A very emotional moment to realise my brother was the same age as this patient and this has stayed with me.

In 2006 I joined GSK as indication lead for pazopanib in advanced soft tissue sarcoma (‘STS’)…
Phase 1 trial had good results of the 6 patients entered… 4 had stable disease by 6 months.

Key milestones for pazopanib in a STS
September 1996 – Program Initiation
Nov 2001 – Candidate Selection
December 2002 – First in Human Dose
October 2005 – 1st STS Patient Dosed (Phase 2)
Sept 2007 – Proof of Concept
March 2008 – Phase 3 Commitment
Oct 2008 – 1st STS patient dosed (Phase 3)
June 2011 – Supplemental NDA Submission
April 2012 – US FDA Approval
August 2012 – EMA Approval

Collaboration with EORTC Soft Tissue and Bone Sarcoma Group Phase 2 and 3
He met with Prof Judson at the Royal Marsden to talk specifically about patient cases. That collaboration has driven the project forward and made him appreciate what a unique community the sarcoma community really is.

Without Sarcoma UK and SPAEN – patients in the UK would not have been able to participate in the PALETTE Phase 3 study. Double blind, placebo controlled trial.

Randomising into placebo without opportunity to cross over within the study.
Without intervention from patient groups it may well have not been able to take place.


Markus Wartenberg – SPAEN, Germany
Status report from the SPAEN task force ‘Therapy and side effect management’. Problems and experiences from other advocates – examples of adherence tools?

Oral targeted therapies:

Often patients attitudes/statements:

  •  I am doing fine, I don’t want to spoil my day with feeling unwell.
  • Nausea /diarrhoea reminds me of having this disease – every day.
  • Drug holidays: to have a great weekend or vacations.
  • Doing well after time: Let’s return to normal life
  • Adjuvant settings: No ‘detectable’ tumour. It’s only for prophylaxis…
  • Poor packaging – complicated dosing schedule – forgetfulness.

Often in reality…
Drs attempts at therapy and side effect management. Attitudes/statements:

  • 5 minutes of information: basis for the therapy offered. Is this enough?
  • Let’s see each other in 3 months….
  • If you have any side effects, contact your GP. Would GPs know?
  • Reduction from 12 to 4 different drugs. This many drugs to manage side effects? Needs to be assessed.
  • Others don’t have this problem. This must be psychologically.Underrated: Dermatology, dental treatment, high blood pressure.

There are also side effects that are not visible to the Dr or the patients.. ie high blood pressure (unless it’s measured before and after). Nausea can’t be measured… and lots more.


  • Modern systemic oral treatments will not work in a patient who does not take his medication.
  • Adherence is an issue but it not only a patient issue. Could this have an impact from the media? Is it that the drugs are provided without a side effect management explained and information. Seeking information from other patients or a patient group where a GP perhaps doesn’t know… consequence is that they may take drug holidays ie underdosed with this type of treatment.

Issues for Healthcare Professionals:

  • Misled assumption: Cancer! My patient is taking his medicine.
  • Often: Lack of expertise, experience, time, maintenance (especially in rare cancers).
  • No/less time dedicated to adherence and therapy/side effect management
  • Problem: Do healthcare systems incentivise maintenance?

Patients may not always report:

  • Side effects (or the full extent of the side effects on their Quality of Life)
  • Drugs holidays or modifications to dosing schedules
  • All of the medications, supplements, treatments they are taking for side effect management.

Factors for adherence and persistence: Paper written by Rob Horne – UCL School of Pharmacy)

  • Personal factors such as where people don’t trust medicine
  • Interaction with the system.
  • Treatment factors that might play a role for the patient. (Dosing. Some instances flexible dosing may be prescribed and have a better effect.)
  • Treatment duration – is it possible to treat on a long term basis if this is better. What’s the situation of progression? Should the drug be stopped? – Side effect management. What about prophylactic? All these need to be considered for Optimum Efficacy.
  • How good is the patient/Dr communication on these issues? What kind of questions are raised by the patient and indeed the Dr.
  • We always talk about ‘the patient’… are we always using the same process for every ‘patient’ or perhaps they should be treated individually.

Maximising patient outcomes with targeted agents:
Target agents: a new era in systematic treatment.
-> Patient needs to benefit from a therapy for as long as possible
-> Three key factors for optimum efficacy
-> Adherence
-> Getting the most out of your therapy.

Joining forces for access, quality, innovations and changes.
Communication and cooperation between all groups including healthcare pharma and patients is needed.

When a survey was conducted they discovered that – Less than 50% knew about the standard supportive actions.

Informing and educating the medical people who, in turn educate the patients.
More awareness and support. Brochures at patient and physicians meetings.

Relaunching new website working on a specific tool as an online database of side effect management. What are the real issues? What are the interaction that patients can do? Hopeful that medics will use it also.

  • Working on a patient guide on therapy and side effect management.
  • Also developed another patient guide, about complementary therapy and nutrition. What can I eat if one of my side effect affects my mouth, ulcers or the like? Patients also have to be aware of the side effects that may be because of the complementary therapy or nutrition etc as it could adversely react to the conventional medicine.
  • Engage with industry to be involved with patient materials. They have to be valuable to patients, patient friendly and written in a way that can be understood by the patients.
  • Physician training for teams on dermatology with oncologists/nurses/Drs. They can then best understand these side effects. Need a combination to work on these issues and involve dermatologists in the process.

Potential activities:
Patient advocacy groups

  • Information education of patients and carers
  • Information about influencing factors – complementary medicine and nutrition
  • Hotlines, info-materials, treatment diaries
  • Together with experts: practical recommendation.
  • Own studies/surveys (Evidence) with support of industry and experts
  • Online – Database “Side Effect Management”
    • Mailing list and/or forum exchange
    • Listings: Centres – best therapy care.

Healthcare industry:

  • Are packaging and dose schedules – is it patient friendly?
  • Studies: side effects not only ‘grading’ but also ‘duration’…
  • Real life studies – reg. dosing and outcome…
  • Congresses, conferences, symposia; Awareness!!
  • Information and education (doctors, nurses, pharmacists, etc)
  • Support/train local networks: Oncologists and nurses and dermatologists
  • Health policy: Compensation for time, communication, support
  • Develop material for patients – BUT together with Patient Awareness Groups
  • If care packages not via Medicals via Patient Awareness Groups (make it measurable on the holistic assessment?)
  • Materials and tools to support adherence
  • Not “company specific” Engagements with other pharmaceutical companies.

Oral target therapies in Sarcomas/GIST:
Professional therapy – and side effect management as the main factor for adherence. Our patients must get the BEST benefit for as long as possible from these kind of treatment with an acceptable quality of life.



Dr Francesco Pignatti, Scientific and Regulatory Management Department, European Medicines Agency, UK (“EMA”)
The process of authorisation for new generic drugs

What are generics?
Defined as essentially similar products. Must contain the same qualitative or quantitative composition in active substances as the originator. Same pharmaceutical form and studies to prove it’s working in an appropriate way.

Approx a 40% saving at the time a generic medicine is introduced.

What data are required?
Chemical, and pharmaceutical aspects (Quality)

  • Same requirements as for the product.

Non-clinical studies (in vitro studies, animal studies)

  • Often no studies required for generic product

Clinical studies

  • Only bioequivalence required for generic product (no need for traditional phase 1-3 development)

In essence: “if the fraction of the dose absorbed is the same, the human body should always do the same with the absorbed compound”

It may be that the ‘packaging’ ie the tablet form or coating makes it’s absorption being different.

Issues related to bioequivalence

  • Biowavier
    • For different strengths
    • Using the BCS classification approach
  • Parent compound versus active metabolite
  • Investigation in fed versus fasting state
  • Handling of outliers

EMA experience

  • Initial evaluation application by type
  • Average active time taken for evaluation is 171 days… no different from other drugs.
  • Rejection rate is about 10%
  • Whenever generic or another drug is approved, it goes on their website and more general information about what generic drugs are

Q. What about the psychological impact of changing from a drug that works to a ‘generic’ drug that they don’t know works?
A. Would have to understand there is a risk and if so what is it.
Q. Why is the patient responding to that drug? Will it be the same with the generic.
A – The active ingredient is the same and it is hitting the target. Objectively it should have no different response. Psychologically it would have to be considered on an individual basis and perhaps needs to be managed accordingly. Patient preference issue should be reviewed by the Dr.


Dr Karen Facey, Honorary Senior Research FelLow, University of Glasgow, Introduction to Health Technology Assessment (“HTA”)
How can patient groups be involved in the process of access to new therapies? – Health Policy Consultant, UK

Health Technology Assessment

  • What do patients have to contribute?
  • Providing evidence to HTA
  • Participating effectively in the HTA process
  • Principles of patient involvement in HTA

Difficult decisions

  • Do new treatments and procedures add value compared to current treatment?
  • Should the health system invest in them?
  • If we invest in a new treatment there is an ‘opportunity cost’ – we must take investment away from somewhere else in the system.
  • How do we decide what the priorities are?

In times of austerity we need to look at how to make a fair decision about how to spend the budget fair for the population we are serving.

How do we decide what to stop investing in?

Since NICE involvement there has been an increasing use of this process called Health Technology Assessment. It’s meant to be a fair systematic evaluation of the clinical effectiveness and/or cost effectiveness and/or social and ethical impact of a health technology on the lives of patients and the health care system. Should we invest to get that amount of benefit?

Health Technology Assessment International

Ethical issues come in strongly for trials.

HTA is being used more and more for where to spend money.

Health Technologies.
A ‘health technology’ is any intervention that may be used to promote health, to prevent diagnose or treat disease or for rehabilitation or long term care.

This includes education, vaccines and much more.

Another part of assessment should be to determine ‘which patients will benefit most from it?’ How long they should get it and if they don’t respond what next?

HTA and decision making is often considered a bridge between scientific evidence and decision-making.

Patients have unique knowledge and perspectives that can inform.

Patients and carers experiences:
Living with an illness

  • No one knows better what it is like to live with an illness day in day out, than those who are doing this – the patients and their family and friends who care for the.

How can patients perspectives in HTA be a route to robust evidence and fair deliberation?

Patients and carers can contribute to HTA

  • By providing EVIDENCE about their experiences and preferences
  • Through PARTICIPATION in the HTA process.

Within the Scottish Medical Commission’s Submission of Evidence Template – SMC 04/12.

Section 3 – views of patients. Carers and families.

Patient evidence:

  • Ideally, concise and balanced overview that reflects the range of patients perspectives
  • Variations in clinical practice
  • Personal perspectives about benefits and difficulties with the technology.
  • Views on rules for starting and stopping treatment
  • Evidence and facts NOT emotions.

Watch the lay people present their case to the Scottish Parliament – Health and Sport Committee Scottish Parliament on 29th January 2013. This demonstrates the importance of presenting evidence, facts and presenting as if a well run business.

Clinical trials vs patient benefit

Some tips about how to gather patient experiences and preparing the evidence:

  • Review helpline questions
  • Survey/questionnaires
  • Social networking
  • Patient stories (videos)
  • Qualitative research (interview, focus groups…)

Build an evidence base!

There is a research project of the HTA – Patient/Citizen Involvement Sub-Group (PCISG)

Through this sub-group there is participation in the HTA process at every stage:

  • Study design to produce evidence
  • HTA topic selection
  • Scoping
  • Submission of evidence
  • Presentation of patient experience to expert committee
  • Sitting on an HTA decision making committee
  • Commenting on recommendations
  • Patient friendly summaries
  • Dissemination/communications
  • Designing and reviewing patient engagement processes
  • Use HTA to inform charity investments
  • Contribution to governmental review of HTA.

Increasing there are opportunities for patients to get involved in designing the patient engagement policies.


  • Population
    • What patients?
    • When an agency starts a process it looks to what patients should be considered.
  • Intervention
  • What medicine, what dose, duration, how’s it administered etc.
  • Comparators
  • Outcome – what matters to patients?

Communicating to a committee

  • Understand your audience and how you are allowed to participate
  • Identify what other experts will be involved and seek to provide unique knowledge.
  • Be prepared with written evidence to refer to
  • Know how long you have to speak – top 3 messages
  • Facts, not emotions.

Tips for writing your consultation response (NICE-IPP)

  • Evaluation of efficacy and safety – not costs.
  • Doesn’t need to be lengthy or comment on everything
  • Short, focussed response
  • Be specific about the procedure
  • Balanced positive and negative
  • No local issues.


Eric Lowe, Chief Executive Myeloma UK
Build your own evidence base – experiences with NICE in the UK

Eric speaks about his involvement on behalf of Myeloma UK with HTA. Taken part successfully in 20 HTA appraisals. Very steep learning curve and some of the toughest experience.

Reimbursement increasingly a huge issue – tremendous problem across the world even in wealthy countries.

HTA is expanding and evolving.

My view is that in 5 years time the UK is going to be a great place as HTA continues to evolve.

Dumbing down health economics, public health doctors and government – empowering HTA.

Biggest mistake of working with patient groups is that they don’t appreciate the wider agenda ie not just about patients.

Work with NICE and help them do their job properly. Help them to create a new environment rather than butt against them.

Being involved…

  • Patient groups need to be crystal clear on what their ole is and isn’t. It’s a huge commitment to be involved in an appraisal so it is important that patients and patient groups are as effective as they can be.
  • They must also try to represent at the patient view beyond the emotional and angry. Got to behave a s a professional cognisant of all the aspects and being able to represent the case.

Being listened to…

  • Need to be seen as both a patient and a key opinion leader
  • They must understand the broad and competing issues around the table and then take up a compelling but balanced and credible position.
  • Early engagement is critical. It is important to go into an appraisal with a detailed understanding of the technology and the opinions and positions of other stakeholders.
  • Patient groups should engage with the company and clinicians to find out their views and opinions.

How early should you get involved?… Phase II study group or before!!

Must ensure that all representatives engage prior to that point to get consensus and agree on the issues and objections. They should work collectively to submit a cohesive and consistent submission rather than sending in several potentially very different submissions which may show that there is a poor understanding and little agreement about the benefits and/or impact of a new technology.

Building evidence…

  • Patent groups need to think about conducting research to provide evidence for their arguments.
  • Anecdotal is not good enough so by conducting studies of patient preference, values and impact etc. puts you in a much stronger position and gives the approval committee more certainty around what impact a new technology may or may not have.
  • Be careful about quality of life.
  • Need to think way I advance of the beginning of the appraisal to give time to conduct, analyse and write up their evidence/data
  • Patients also have a role in ensuring the clinical evidence is fit for purpose.
  • Patient groups also need to encourage industry to work with NICE Scientific Advice and also attempt to influence the clinical trial designs of registration studies or to encourage additional evidence development to address the evidence gaps. The service is available to help… only 10% of companies use the service!!!

Myeloma UK have established a national clinical trials network. We worked with pharma ahead of time, looked at the trial compared to NICE and then designed a phase 2 academic study to deal with.


  • Reimbursement issues are increasingly challenging
  • HTA is here to stay, is evolving and expanding.
  • Specialist expertise is needed
  • Inputs needs to be better, crap in crap out. Much more important than that… it’s based on a Phase 3 Global Licensing study… quite often that is very different to clinical practice… even if NICE say yes to the drug we need to make sure we can translate it into effective clinical practice.
  • Done properly it’s a good thing and patient groups should embrace it and make it work for them.
  • HTA is only part of the process and not the end.

Be partners and help involve HTA from the inside.

Cancer Research – “Your Say, Your Day, Your CRUK” event

Today’s excitement was that I have been invited to attend a Cancer Research UK event in London.  10 other similar events are taking place around the UK simultaneously with the hope that together we (at all 11 events) will provide Cancer Research with valuable input with regard to more patient/carer engagement in research together with policy and campaigning.

In London there were approximately 100 patient/carers in attendance and I was really pleased to note that Cancer Research had been able to get a good balance of men, women, older, younger, working, not working and different stages of cancer diagnosis/treatment/remission.  I’m always very aware that often the people who dedicate time to attend these events are often those who are no longer working and often older – we need to get more younger participants so that the views of young adults, new parents etc are also represented.  But Cancer Research appear to have done this today!

IMG_3998Having just made that point all girls in this pic!

The day’s agenda is focusing mainly on two main discussions (below) followed by a talk by Professor Bob Brown, Head of Division of Cancer and Chair in Translational Oncology at Imperial College.  Then (thanks to technology) a message broadcast to all locations by Harpal Kumar, Chief Executive of Cancer Research UK.

The first discussion – Involving people affected by cancer in research.  On our table it was a lively discussion leading to our facilitator writing super fast to take down all the notes.  We divided the discussion into three main categories:

  • What patients could be involved in
  • Helping to train researchers in how to talk to patients
  • What motivates people to be involved.

In summary (and believe me this post would be pages long if I put it all down), we said that we believed patients/carers should be involved in everything Cancer Research did.  We asked that there should be more of an open dialogue between the organisation and patient/carers.  We could help with reviewing documentation, website, information and also media.  Don’t assume that patients won’t want to be involved, have an opinion or perhaps enhance the services and products.  We advised that patient/carers can provide input at meetings, events and in person but also by email or via online surveys and forums.  This additional way would allow people who aren’t able to leave the house to also provide their input.  Could the researchers/scientists provide more information to the patient/carers about what they do?  Perhaps tours of research facilities.  Leaflets and newsletters with updates.  We also asked if results could be published… even for projects that didn’t complete or failed.  Collaborative working between the researchers and the users… think of it like translational research!  If we can take research from the lab bench to the patient bedside then we should consider the same for patient/carer involvement.

We suggested that patients/carers who were advocates or past clinical trial patients could train utilise their experiences to train others.  Nurses and doctors could understand the patient journey with regard to clinical trials.  What they had been worried about.  What could have been explained differently or in more/or less detail.  What their experience was and why it was important to them to participate.  We felt that these people could also be part of a video/tv campaign to educate the public about clinical trials.  Not just the ones that include taking medicines or drugs but also those that mean tissue samples being sent from operations or perhaps completing surveys or research about side effects etc.  So many people, until they need to understand, don’t come into contact with clinical trials and therefore many just remember the ‘elephant man’ trial a few years ago and assume this risk for all.  Utilising the patient/carer message could dispel this myth and many more and encourage people to always consider a trial as part of their medical journey (if available).

Patient/carers input needs to be valued.  After all, all these people were also someone before they were diagnosed or cared for someone who was.  Maybe worth remembering that in one chemo ward an organisation may have all the skills they need for the whole project AND now they all have first hand experience too!

What motivates people to get involved?  In the most part the answer is usually because they have been affected by  cancer.  However it can’t always be assumed that this is the case as often it may be more altruistic.

Everyone needs to be realistic and understand the requirements on the participants.  Perhaps they have time but don’t have energy.  Perhaps they have a great deal of time at the moment but know they have treatment coming up.  Perhaps they want short term assignments or to help remotely.  Ask.  Ask the participant and also build rapport so that they don’t feel overwhelmed or ‘put upon’.  We discussed that usually you get a better response and longer involvement.

The second part of our day regarded ‘Involving people affected by cancer in policy and campaigning’.

Something that was raised in the earlier part of the day was that patients and carers should be involved in deciding WHAT is to be campaigned for and what policies were prioritised.  We felt it was a little patronising to be told what we should be campaigning for without knowing that there was sufficient patient/carer input at the start of the discussion.  After all if it was something we were passionate about, would we not then put more emphasis on getting the message heard?

We asked for training, support and feedback for all participating.  For many public speaking is part of their career however for some talking about something so personal can be difficult.  Perhaps as part of the training use other patient/carers who have previously spoken publicly to talk about their experiences, how they overcame their nerves, what they felt got the point over etc.

We also felt that it was important for Cancer Research to publicise more the work they do with regard to influencing policy and campaigning.

This posting is only part of what was discussed and Cancer Research have also put together a blog with some more of the points raised.  Do post any feedback or comments on their page.

In London, we were also treated to a performance by the Combination Dance Company – Code.  Code are preparing a performance project that will be seen throughout the UK which will, through dance, words and music, tell a story about cancer and particularly research.  Do keep an eye out for Code where you are.  In the meantime you can follow their progress on Facebook and Twitter.

International Clinical Trials Day

Each year, International Clinical Trials Day is celebrated around the world on or near the 20th May to commemorate the day that James Lind started his famous trial.

Tonight I’ve been a guest of Cancer Research UK at their Imperial Cancer Research UK Centre in West London. The purpose of tonight’s celebration is to launch a series of short films which feature key research programmes currently being undertaken. These films will be displayed in public areas within partner hospitals and for use by the teams on websites and during public and patient involvement events.

As you know I’m passionate about the improvement and advancement of cancer care. I have spent time to try to understand what clinical trials really involve. What is being undertaken and where. Why people should get involved (greater good and personal good). I can’t stress enough that without patient and carer involvement, medical advancements will be slow or in some cases not exist at all!

Clinical trials used to fill me with fear. I thought, as I think many do, that being involved in a clinical trial would mean being injected with drugs, high levels of danger and perhaps ending up like the Elephant Man case or worse.

What my investigations and questions have led me is truly a very different understanding. There is so much more to clinical trials and a great deal of it non-invasive. Participation can be as little as completing surveys or questionnaires during your treatment or whilst caring for someone else. It may be changing your diet slightly. It may be helping with the wording on a funding application from a patient/carer perspective. It might be the occasional blood sample. It may be speaking to researchers about your experience first hand. It may be donating part of a excised tumour. It may be regular scans. It may also be changes to your chemotherapy regimen, radiotherapy frequency or taking new drugs.

However with all patient/carer involvement there is a huge duty of care to ensure you understand your involvement, the level of involvement. Continued support and, if you’re participating in drugs trials, constant access to the clinical and research team.

They can’t do their work without us!

Personally, I’ve authorised for tumour samples from my excised Phyllodes to a tissue bank for a clinical trial relating to Phyllodes. Sadly due to the small number diagnosed the trial remains on hold whilst new samples are slowly collected.

I’ve also authorised for tumour samples from my excised DCIS to be used in a trial. This trial is known as the ICICLE trial and there is a brief explanation from Cancer Research about what it is researching.

As part of the Patient Participation Group at Imperial, I’ve also helped out with the wording of funding applications, trial designs and patient/carer leaflets. I’ve participated in discussions and provided feedback at meetings to researchers and clinicians. I’ve also been fortunate enough to have a tour of the research centre and see exactly where the work is carried out, the scans performed, the ward for inpatients and consultation rooms. Amazing facility. Incredible work.

So I guess it’ll come as no surprise to anyone that I’ve been involved in another project at Imperial. The only surprise is that I’ve put myself in front of a camera – I so hate myself on film! But needs must.

As I mentioned earlier, tonight saw the launch of a number of films. Well yours truly appears in a couple of them! Even more so, I was presented with a lovely gift from the team at Imperial to thank me for my involvement and all that I contribute to the group.

I hope the films make a difference and encourage people to get involved in clinical trials… remember they’re not scary!

Here are a few films that explain what taking part in a clinical trial involves and below there are more specific trial information films.….

Link to films – I may well appear in them so don’t be scared!