Science and Technology CommitteeWritten evidence submitted by Sense About Science

This is a memorandum about patient and public support for clinical trials reporting, and in particular the support from participants in clinical trials, in response to Questions 3 and 4 set out by the Committee. Sense About Science is making a separate submission about the effects of publishing the results of clinical trials.

1. Background

1.1 Sense About Science established the AllTrials campaign with Bad Science, BMJ, James Lind Initiative and Centre for Evidence Based Medicine. AllTrials is calling for all clinical trials to be registered and results to be reported, from both industry and academia. The best available evidence shows that about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely not to be published.1 There have been years of discussions about addressing this problem but they have been slow and have failed to produce a decisive public commitment.

1.2 The campaign was launched on 9 January 2013. The AllTrials.net petition has been signed by over 30,000 individuals and 178 organisations including 97 patient groups. Appendix 1 contains the petition text and the names of the supporting organisations.

1.3 Sense About Science is a charity that equips people to make sense of science and evidence. We are a source of information, we challenge misinformation and we champion research and high quality evidence. We work with thousands of scientists, scientific bodies, research publishers, policy makers, the public, community groups and media, to promote sound science and evidence in public discussions.

2. Clinical Trial Participants

2.1 On 18 January 2013, fifty three clinical trial participants wrote to the European Medicines Agency (EMA) saying that the lack of regulations requiring clinical trials to be published is a betrayal of their trust. They said: “we all agreed to participate in the trials in the belief that we were helping to improve knowledge and treatments. We now understand that many participants in trials have been misled... This means that the findings generated from our participation and that of thousands of others in the trials may not be available to the doctors, researchers and regulators who work on particular diseases or make decisions about their treatments. It also means that some of the trials could be repeated in the future, when they do not need to be.” (Appendix 2)

2.2 The signatories to the letter asked the EMA to put in place measures to ensure that the protocols for all clinical trials from now on—and all clinical trials since the 1980s—are posted on a public register; and that the primary and secondary outcomes measured in all these trials and the clinical study reports are published.

2.3 Richard Stephens, Chair of the NIHR Cancer Consumer Liaison Group, who signed the letter as a cancer patient and clinical trial participant said, “The Department of Health report, Innovation Health and Wealth, sets out a goal for the NHS that every willing patient should be able to take part in research. In our publication, Action On Access, we call for research to be embedded in clinical practice. Already 20% of cancer patients in the UK take part in clinical trials as part of their treatment options. We expect that the results of trials will be made freely available to researchers, clinicians and administrators, in order to deliver better treatments, better services, and better outcomes for patients. So all clinical trials should be on a central accessible register, and all trials should be reporting their results, even if they do not change clinical practice. Patients who choose to take part in clinical trials believe that by doing so, we are helping other patients in the future. I believe it is immoral to recruit patients to clinical trials and then not report or share the results. We participate in order to increase knowledge and to help others. We do not expect the knowledge to be kept secret or the help for others to be denied.” (Appendix 3)

2.4 GSK signed up to the AllTrials petition on 5 February 2013. Their statement set out their plans to publish the full results of all the trials they have conducted going back to their formation as a company. It also recognises the concerns of patients: “Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”2

2.5 Between 16 and 18 of January 2013, Sense About Science conducted a survey through PatientView (which has access to an international network of 120,000 patient groups). The results of this survey indicated that 75% of people who have a medical condition (and 72% of all respondents) say that they would be more likely to take part in a clinical trial if they knew the results would be published. (Appendix 4)

3. Recommendations

3.1 Where they have not already been registered, all clinical trials for medicines in current use should be registered retrospectively in an approved public registry. This is because the majority of prescription drugs currently in use were licensed before 2007 (FDA regulation amendment).

3.2 Clinical trials which have not been part of a marketing authorization (licensing) application should also be registered retrospectively. This will contribute to better clinical research and avoid repetition of clinical trials (and therefore unnecessary risk to patients and expense).

3.3 For all trials (phase 2 and above) conducted since 1990:

Full clinical study reports, or equivalent, should be made publicly available.

Where these are not available, a written statement should be provided, signed by the current Medical Director or Principal Investigator, stating that the clinical study reports and/or results are unavailable; explaining when and why they were destroyed; stating what efforts have been made to find the relevant documents; and sharing whatever information is still available about the trials (such as protocol, clinical indication, size, etc).

3.4 For all future trials, regardless of location or indication:

The trial should be registered on an ICMJE recognised registry before recruitment of the first patient.

Summary results and full clinical study reports (or equivalent) should be available within one year of completion (with an explanation provided in any case of delay).

3.5 The EMA intends to publish data that has been submitted for marketing authorizations from 2014. It should provide registry space for trials which are not part of such applications and lead the retrospective registration and reporting in 3.1–3.4, providing space for links to be provided to clinical study reports or equivalent held on other databases.

3.6 The Association of the British Pharmaceutical Industry’s response to the AllTrials campaign has been disappointing. After some initial obfuscation it has said that it is going to wait for EMA working groups to report. These groups are not directly considering the proposal to publish clinical study reports, or equivalent results for other types of intervention studies, for all trials and for all treatments in current use (ie the medical treatments we actually use, which are already licensed, rather than just the small percentage that will be licensed and used in the future). Clinical study reports do sometimes contain some patient level data. GSK is resolving this by redacting it where necessary.

Since AllTrials started, it has become clearer by the day that this is moving in only one direction, as thousands of doctors, researchers and members of the public sign up. In a few years time it will be hard to imagine how anyone could have defended the current situation.

February 2013

APPENDIX 1

ALLTRIALS PETITION AND SUPPORTING ORGANISATIONS

Thousands of clinical trials have not reported their results; some have not even been registered.

Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

All trials past and present should be registered, and the full methods and the results reported.

We call on governments, regulators and research bodies to implement measures to achieve this.

Signed by:

Adelaide Health Technology Assessment

American Institute for Technology and Science Education

American Medical Students Association

Association of Clinical Biochemistry

Association of Medical Research Charities

Association of Research Ethics Committee

Belgian Centre for Evidence Based Medicine

Berne Declaration

BioMed Central

British Library

British Nutrition Foundation

British Society for the Study of Vulval Diseases

Canadian HIV Trials Network

Centre for Reviews and Dissemination

Centre for Statistics in Medicine

Centre of Evidence Based Dermatology

Chemist and Druggist Magazine

Clinical Pharmacist

Cochrane Collaboration

Committee On Publication Ethics

Critical Appraisal Skills Programme

Critical Appraisal Skills Programme International Network

Critical Appraisal Skills Programme Mexico

Critical Appraisal Skills Programme Spain

Dianthus Medical Ltd

Doctors Reform Society

Drugs and Therapeutics Bulletin

eCancer

Equator Network

European Continuing Medical Education Forum

European Federation of Clinical Chemistry and Laboratory Medicine

Faculty of Intensive Care Medicine

German Network for Evidence Based Medicine

GIMBE Foundation

GSK

HealthWatch

Health Action International Europe

Health Action International Global

Healthy Skepticism UK

Hospital Pediátrico de Sinaloa

IBase

Idea Pharma

Ideal

Institute for Quality and Efficiency in Healthcare

Intensive Care Foundation

Intensive Care Society

International Coalition for treatment preparedness in Eastern Europe and Central Asia

International Institute for Advanced Studies of Psychotherapy and Applied Mental Health

International Society for Evidence Based Health Care

Journal of Cognitive and Behavioural Psychotherapies

Journal of Kathmandu Medical College

London School of Hygiene and Tropical Medicine

Medical Research Council

Medicos Sin Marca

Medsin

Minervation

National Physicians Alliance

Netherlands Epidemiological Society

NICE

No Grazie Pago Io

North London Humanist Group

Norwegian Knowledge Centre for Health Services

Nottingham Clinical Trials Unit

Open

Open Knowledge Foundation

Open Science Federation

Oxford Vaccine Group

Pharmaceutical Journal

Pharmaware

PLOS

Royal Statistical Society

Russian Society for Evidence Based Medicine

Sabre Research UK

Tatarstan Medical Student Association

Thinkwell

Trip

UK Clinical Pharmacy Association

UK Dermatology Clinical Trials Unit

UK Research Integrity Office

Wellcome Trust

World Association of Medical Editors

Patient Groups

AIDS Coalition to Unleash Power Paris

Lymphoedema Support Network

AIDS Treatment Activists Coalition

Lymphoma Association

Action for M.E

Macmillan Cancer Care

Age UK

Macular Society

Action for Sick Children

MDS UK Patient Support Group

Afiya Trust

Migraine Trust

Alkaptonuria Society

Motor Neurone Disease Association

Alpha 1 Awareness UK

Mouth Cancer Foundation

Alzheimer’s Society

Muscular Dystrophy Campaign

Anticoagulation Europe

Myeloma UK

Arrhythmia Alliance

MS Society

Arthritis Care

National Ankylosing Spondylitis Trust

Asthma UK

National Association of Deafened People

Beat

National Childbirth Trust

Bliss

National Osteoporosis Society

Blood Pressure Association

National Rheumatoid Arthritis Society

Bowel Cancer UK

National Voices

Brain and Spine Foundation UK

NI Chest & Stroke

Breakthrough Breast Cancer

Norwegian Cancer Society

Brains Trust

No Panic

Brain Tumour Charity

Pain UK

Bristol and Avon Chinese Women’s Group

Parkinsons UK

British Dupuytren’s Society

Patients Association

British Heart Foundation

Patients Involved in NICE

British Obesity Surgery Patients

Pelvic Pain Support Network

British Lung Foundation

The Pernicious Anaemia Society

Cancer Research UK

The Pituitary Foundation

Cardiomyopathy Association

Prostate Cancer UK

Changing Faces

Positive People Armenian Network

Crohn’s and Colitis UK

PXE (PiXiE) Europe

Counsel and Care

Rare Disease UK

CSV

Rethink

Cystic Fibrosis Unite

Royal National Institute of Blind People

Diabetes UK

Royal Society for Public Health NGO forum

Different Strokes

Sarcoma UK

Disabilities Trust

Sarcoma Patients Euronet

Ear Foundation

Scleroderma Society

Encaphalitis Society

STARS

Epilepsy Action

Stichting Tekenbeetziekten

Epilepsy Society

Stonewall

Genetic Alliance UK

Target Ovarian Cancer

ITP Support Association

Terrence Higgins Trust

INPUT

Treatment Action Campaign

James Whale Fund for Kidney Cancer

Treatment Action Group

June Hancock Mesothelioma Research Fund

Together for short lives

Kidney Alliance

Urostomy Association

La Leche League GB

Well UK

Leukaemia CARE

Young Minds

Lyme Disease Action

APPENDIX 2

LETTER TO THE EMA FROM CLINICAL TRIAL PARTICIPANTS

We have participated in clinical trials in the last 30 years.

Some of us are healthy individuals and some of us have medical conditions. Some of us probably received the treatment under investigation in the trial and some of us were given the control treatment or placebo.

Whatever the case, we all agreed to participate in the trials in the belief that we were helping to improve knowledge and treatments. We now understand that many participants in trials have been misled. Current evidence shows that, overall, about half of all clinical trials have not been published and that this proportion has seen only a small improvement over the past few years. Furthermore, both companies and independent researchers can withhold information about clinical trials from doctors and researchers even when asked for it.

This means that the findings generated from our participation and that of thousands of others in the trials may not be available to the doctors, researchers and regulators who work on particular diseases or make decisions about their treatments. It also means that some of the trials could be repeated in the future, when they do not need to be.

This is dangerous and expensive and it holds back good medicine. It is also a betrayal of our trust in clinical trial regulation, and the trust of the families of those patients who volunteer for trials having had a terminal diagnosis.

The Clinical Trials Regulation is currently being debated in the European Parliament. We want you to put in place measures to ensure that the protocols for all clinical trials from now on—and all clinical trials since the 1980s—are posted on a public register; and that the summary results, the “primary and secondary outcomes” measured in all these trials and the Clinical Study Reports are published.

Name

Description of trial

Date of trial

Iain Chalmers

Oxford Vaccine Group’s test of a new pneumococcal vaccine

c 2008–2009

Richard Stephens

Trial of drug combinations in Lymphoma

1998

Trial of PET scans as prognostic indicators in Lymphoma

1999

Trial of blood anti-clotting agents in heart patients

2007

Lauren Gore

Test of potential new eczema treatment on healthy volunteers.

August 2012

Richard Smith

The trial was a double blind randomised controlled crossover trial to see if the polypill would reduce blood pressure and blood lipids. It lasted about six months. The polypill did reduce blood pressure and blood lipids.

2011

Sarah Stevens

Undertaken at St Barts Hospital for GW Pharma to assess affectiveness of Sativex for muscle spasms (trial was double blind). Condition: multiple sclerosis.

c 2006

Dominic Haigh

TREK Study Description: Participants from several different European countries were given either a patch immunising against traveller’s diarrhoea or an inert placebo and dispatched to countries where they might become infected with the disease. I went to stay in Guatemala City for a week.

January 2010

Nancy Kane

Beta SNP trial; study examining whether differences in genes affect how vitamin A is used by the body.

October 2012

Ralph Cantellow

The PACE trial was a randomised controlled trial of treatments for chronic fatigue syndrome also known as myalgic encephalomyelitis or myalgic encephalopathy. The trial, which involved 640 patients, was conducted in six hospitals in England and Scotland and compared the safety and effectiveness of four treatments: Specialist medical care (SMC) alone, and SMC plus one of the following therapies: adaptive pacing therapy cognitive behaviour therapy, and graded exercise therapy.

March 2003–January 2010

Mei Lee

Phase 3 trials of Novartis’s vaccine against neisseria meningitides B

2009–2010

Sam L

It was an antidepressant study looking at drugs affecting glutamate (ketamine and a new drug AZD6765)

February–March 2010

Charis Croft

The trial is between subcutaneous injections and sublingual tablets as a mechanism for administering immunotherapy to relieve hay fever arising from grass pollen.

September 2012–ongoing

Joanne Evans

Trialling BMN110 enzyme replacement therapy for Morquio’s Syndrome (Mucopolysaccharide IVA)

August 2011–January 2012

Phil Booth

Trials of anti-epilepsy and pre-diabetes treatments

1988–1989

Rachel Pearce

My trial is called SOFT (Suppression of Ovarian Function Trial) and is a 3-arm trial testing the benefits and disadvantages of: Tamoxifen, Tamoxifen + ovarian function suppression, Exemestane + ovarian function suppression in premenopausal women with hormone receptor positive breast cancer.

2003–2011

Thomas Edward Hills

Single dose of a generic formulation of bicalutamide (anti-androgen for prostate Ca)—pharmacokinetic study.

c June 2005

Helen Ap-Rhisiart, on behalf of my daughter, now aged twelve

Oxford Vaccine Group (Univ Oxford) meningitis C/pneumonia combination vaccine study.

2000–2003

Brian Sewell

Trial for a drug to control high blood pressure

1992

Caroline Richmond

Vitamin C and the common cold

c 1984

MRSA in denture wearers

c 2005

COPD

2013

Ryan Geleit

First into human trial to assess a new compound for the treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome

February 2012

Richard Desmond

Concorde trial into the efficacy of treating infection with HIV

1989–1991

A’Llyn Ettien

Yearlong trial of drug combination to prevent bone thinning

2005–2006

3-month trial of birth control patch comparing usability to ring

Summer 2007

James Warwick

Final phase RCT for a new meningitis vaccine developed by Novartis

October 2010–2011

Kevin Nickells

Clinical trial into the affects of alcohol on nicotine dependency

August 2010

Michael Wing

The trial was based at St Georges Hospital, Tooting, London. I underwent 12 hours of an intravenous infusion of deuterium enriched water preceded and followed by a blood test. I also had a repeat blood test 2 weeks later. The study was to identify the maturation rate of lymphocytes.

2001–2002

Khairil Hodgson

FluCamp a phase 2a, randomized, double blind, placebo controlled study to Investigate the effects of VX 787 administered to adult volunteers experimentally inoculated with live influenza virus

August 2012

Dr Aaron Dale

Addenbrookes Hospital for GSK for a painkiller

2007

FluCamp to test an influenza vaccine

December 2012

Kathryn M Burke

The trial was Fingolimod (Gilenya) phase III. The trial was to test safety and efficacy.

2007

Harry Purser

Trial for a peripheral system analgesic.

April 2010

Gillian Lang

During pregnancy my blood pressure was monitored and samples of placenta taken following the birth

March–November 2002

Hester Tidcombe on behalf of my son

Post-authorisation safety study of GSK’s pandemic flu vaccine in the UK

November 2009

Chris Murphy

For diabetes

Autumn 2004

Hilary Foote

The effects of natural bran food supplement on irritable bowel syndrome

c 1994

Michael James Fox

The trial was for the norovirus

Summer 2009

Darran Shepherd

Malaria vaccination trial

January 2010

Christopher John Parlett

I participated in three medical trials at the Department of Respiratory Medicine and Allergy, King’s College, London All trials were said to be for the testing of alternatives to current corticosteroid treatments for asthma.

2001–2003

Denise Syndercombe Court

Tamoxifen +/- (Zoladex) randomised- given for 2 years duration. Given for stage I/II breast cancer in premenopausal women (including those with positive nodes)

1994–1995

Linton Lahoud

Effects of light on sleep

c 2011

Dr Gemma Bashevoy

A trial for a malaria vaccine

January 2011–September 2012

Dr Maxim Bashevoy

A clinical trial for hay fever using a drug called rPhleum (immunotherapy)

c 2009

Nicola Branch

Trialling a gel to help reduce the spread of HIV amongst heterosexuals in Africa

2004–2005

Leslie Rose

Phase I study of effects of a beta-blocker on muscle blood flow. Injection of a radio-label into anterior tibialis muscle, followed by treadmill exercise testing.

1980

Acupuncture in neck pain. The purpose of the study was to evaluate electro-acupuncture in comparison with normal acupuncture and placebo electro-acupuncture.

2004

Adam Barnett

Katherine Hunter

Kieran Crean

Matthew Valentine, MD

Roche trial of Oseltamivir (Tamiflu). Recruited with active flu-like illness as a medical student at Oregon Health and Sciences University in Portland, Oregon, USA for randomized controlled trial of Oseltamivir

Autumn 1998

Amanda Burls

The intervention was probiotic yoghurt versus non-probiotic yoghurt for IBS

2005

Martin Law

Get Moving run by the MRC epidemiology Unit

October 2012–February 2013

Carmen Major

Cynthia Dumas

Phase III randomized study of treatment based on response to induction chemotherapy in patients with higher risk childhood acute lymphocytic leukaemia

April 2001- July 2003

Amanda Kerr on behalf of my son

Infant vaccine trial

2008–2009

Sean Murphy

Interaction of an antihistamine and an anti-fungal drug

1993

Interaction of a 5HT1A receptor agonist and alcohol.

1993

Veronica Klein

Michelle Fraser

APPENDIX 3

NOTE ON PUBLICATION OF THE OPEN LETTER FROM CLINICAL TRIAL PARTICIPANTS TO THE EMA

Fifty-three clinical trial participants have written to the European Medicines Agency pointing out that the lack of regulations requiring clinical trials to be published is a betrayal of their trust.

Tracey Brown, Director, Sense About Science: “There is no good reason to delay full reporting of clinical trial results. It will have huge benefits for patients, health workers, doctors, pharmacists, regulators and researchers. It will benefit treatment decisions now and research into future options and it will encourage more people to be involved in clinical trials. The first tranche of results from our international patient survey1 is showing that 78% of people who have a medical condition (and 72% of all respondents) say they would be more likely to take part in a clinical trial if they were assured the results would be published.”

Ben Goldacre, doctor and author of Bad Pharma: “We need the results of clinical trials to make informed decisions about which treatment is best, but half of all such trials have never been published, which exaggerates and distorts the evidence we have. This is medicine’s dirty secret, so it’s great to see patients speaking out, and so many eminent organisations joining up, to finally fix this problem. Withholding trial results is indefensible, and should never have been allowed to happen.”

Carl Heneghan, Director, Centre for Evidence-Based Medicine, University of Oxford: “When trial results aren’t published substantial harms occur, patients die and ineffective treatments waste precious health care resources. Is this what patients expect when they sign up to consent in a trial? Certainly not.”

Comments from signatories to the letter:

Richard Stephens who signed the letter as a cancer patient and clinical trial participant: “The Department of Health report, Innovation Health and Wealth, sets out a goal for the NHS that every willing patient should be able to take part in research. In our publication, Action On Access, we call for research to be embedded in clinical practice. Already 20% of cancer patients take part in clinical trials as part of their treatment options. The National Cancer Patient Experience Survey (2012) showed that two thirds of cancer patients are open to being asked about participating in research, and of those who are approached, 95% are glad to have been asked, even if they choose not to participate themselves.”

“Patients who choose to take part in clinical trials believe that by doing so, we are helping other patients in the future. We expect that the results of trials will be made freely available to researchers, clinicians and administrators, in order to deliver better treatments, better services, and better outcomes for patients. So all clinical trials should be on a central accessible register, and all trials should be reporting their results, even if they do not change clinical practice. I believe it is immoral to recruit patients to clinical trials and then not report or share the results. We participate in order to increase knowledge and to help others. We do not expect the knowledge to be kept secret or the help for others to be denied.”

Iain Chalmers took part in the Oxford Vaccine Group’s test of a new pneumococcal vaccine, c2008–2009: “I agreed to a request from the Oxford Vaccine Group to participate in a trial of a new formulation of pneumococcal vaccine. I asked to be sent the results of the study, and was assured that I would be; but I wasn’t. When I received a request to volunteer for another vaccine trial being done by the same group I rang to ask to see a copy of the protocol, but I was informed it was confidential. I declined that invitation, and will do so for any future invitations I receive from this research group until this problem is solved.”

Phil Booth took part in trials of anti-epilepsy and pre-diabetes treatments, 1988–1989: “I volunteered to do clinical trials on the understanding they would help people. If the results of any trial aren’t published, how can doctors know what’ll help their patients and what might harm them? Had someone with diabetes reacted to the test drug I took in the way I did, they might have died. There’s no excuse for hiding data like that.”

A’Llyn Ettien took part in a yearlong trial of drug combination to prevent bone thinning, 2005–2006: “I would hate to think that the time and effort I and other participants invested in multiple visits to the trial centre, repeated evaluative tests, and complying with a drug regimen for an entire year was wasted because the data wasn’t made public. The compilation of that many person-hours (never mind the time of the researchers themselves!) deserves to be put to use by being made available to help inform the next people who want to study this topic--regardless of the outcome.”

Charis Croft took part in a trial comparing different ways to administer immunotherapy for hayfever, September 2012–ongoing: “As a trial participant, I had a couple of motivations for signing up. One, of course, is the hope that in the course of the trial I receive an active therapy that improves my condition. But the odds of receiving the placebo are relatively high, and the therapy may not be effective. So there has to be an additional motivation. And certainly for me, and I think a large number of my fellow participants, there is a very strong motivation in the knowledge that we are contributing to scientific knowledge and understanding of our condition and ways to treat it. It’s at least half of the reason we do it. If the results are not released, then we are not contributing to the wider scientific understanding. That is a massive betrayal of our trust and the implicit contract between researchers and patients. This must be addressed. There are no options except action.”

Hilary Foote took part in a trial on the effects of natural bran food supplement on irritable bowel syndrome, c 1994: “When I was asked to take part in the study I wasn’t very keen on the idea as it would intrude on my daily personal life in an intimate manner. However I felt a sense of duty because I was aware that I have benefited from other people taking part in trials in the past. Having found out about how trials often go unreported I would be very reluctant to take part in any trial in the future. I will certainly not take part in any commercially funded trial unless suitable legislation is brought in.”

Dr Aaron Dale took part in a trial for a painkiller in 2007 and in FluCamp to test an influenza vaccine in December 2012: “It is essential that data from all clinical trials, both positive and negative, is accessible to doctors and their patients, to enable them to make the most informed and suitable decisions about their treatments and medications.”

Dominic Haigh took part in a trial on treatments for traveller’s diarrhoea in January 2010: “Trials are the best tools that we have to test ideas in medicine. Ideas and medicines which may in theory be beneficial may in fact do great harm. Only trials can separate facts from theories.”

Nicola Branch took part in a trial on a gel to help reduce the spread of HIV amongst heterosexuals in Africa, 2004–2005: “I think trials are very important to enable scientists to develop drugs and other medical products to improve treatments for people around the world. Trials are not risk averse and people who participate in them should be given full access to information about what’s involved hence the need for a register. And one where we as ‘guinea pigs’ can leave uncensored comments about our experiences.”

APPENDIX 4

SURVEY OF PATIENT GROUPS AND MEMBERS ON CLINICAL TRIAL PARTICIPATION
CIRCULATED BY PATIENTVIEW TO THEIR INTERNATIONAL NETWORK OF PATIENT GROUPS. RESPONSES COLLECTED BETWEEN 16/1/13–18/1/13

Total Number of Respondents: 195

Would you be more likely to take part in a clinical trial if you knew the results would be published?

More likely

139

71.28%

The same

44

22.56%

Less likely

4

2.05%

Don’t know/not relevant to me

9

4.62%

Have you ever participated as a volunteer in a clinical trial?

Yes

55

28.35%

No

139

71.65%

Have you ever been asked to participate as a volunteer in a clinical trial but didn’t do so?

Yes

29

14.87%

No

166

85.13%

Number of Respondents who are Patients: 111

Would you be more likely to take part in a clinical trial if you knew the results would be published?

More likely

83

74.77%

The same

25

22.52%

Less likely

1

0.90%

Don’t know/not relevant to me

2

1.80%

Have you ever participated in a clinical trial?

Yes

39

35.14%

No

72

64.86%

Have you ever been asked to participate as a volunteer in a clinical trial but didn’t do so?

Yes

15

13.51%

No

96

86.49%

1 F Song, S Parekh, L Hooper, Y K Loke, J Ryder, A J Sutton, C Hing, C S Kwok, C Pang, I Harvey. Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010; Vol. 14: No. 8 http://www.hta.ac.uk/fullmono/mon1408.pdf

2 GSK announces support for AllTrials campaign for clinical data transparency http://www.gsk.com/media/press-releases/2013/GSK-announces-support-forAll-Trials-campaign-for-clinical-data-transparency.html

Prepared 16th September 2013