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. Read the letter here (PDF).

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: “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.”

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.”

Signatories are not commenting on the conduct of the particular trial they participated in but on the wider problem of lack of regulations for clinical trial publication.

Press coverage:

Trust of medical volunteers betrayed: BBC Online blog by Fergus Walsh

The Today programme: interview with Sir Iain Chalmers, one of the signatories of the letter and Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry

*The European Medicines Agency is the regulatory body responsible for the scientific evaluation of medicines for use in the European Union.