Select Committee inquiry publishes evidence on clinical trial transparency

House of Commons logoThe House of Commons Science & Technology Select Committee has published a transcript of the first session of oral evidence given to its ongoing inquiry into transparency of clinical trial data and reporting. The written evidence submitted to the inquiry by over 60 organisations, companies and individuals has also been published.

Professor Sir Michael Rawlins (Chairman of NICE and of the Academy of Medical Sciences review of clinical trial governance), Dr Fiona Godlee (Editor of the British Medical Journal) and Dr Keith Bragman (President of the Faculty of Pharmaceutical Medicine) answered questions giving a thorough overview of the issues around the value of making clinical trial reports and patient level data available to the medical profession and to the public, but also some of the challenges that will need to be overcome in order to do this.

In answer to one question, Fiona Godlee stated, “It is an international challenge, and the solutions have to be international. We look to Europe, and recent events suggest that the EMA is taking this seriously, but whether it will be able to do what it now wants to do is obviously something that we are watching with great concern.”

Professor Rawlins said that publishing trial data could “potentially be very important and helpful, either to reanalyse them in a different way or to merge the results of different trials so that, instead of a trial of 10,000 patients, you have 10 trials of 100,000 patients. … My big worry is ensuring the privacy of the patients. However well you anonymise it, particularly if you are talking about the rarer diseases, you can de-anonymise it and identify them. Because these meta-analyses or this single patient data are so valuable, we need to develop a mechanism whereby there is some sort of safe haven to ensure that the people who have access to the data are going to use it responsibly, particularly when it comes to the privacy of the participants.”

Dr Bragman added that the current system is “eroding belief in medicines because people cannot trust the results that are published. … If we do not know what we can believe, the whole system suffers. Belief in medicine suffers, patients do not take their medicines properly, the benefits that can be derived from medicines suffer, and it costs the NHS more money at the end of the day. This is something that we need to put right.”