The proposed EU Clinical Trials Regulation would do some good things, especially on ensuring that all trials conducted in Europe are registered before they start. We don’t know what was found in thousands of past trials and, because many trials weren’t even registered there’s no 'index' against which non-publication of results can be checked. These past results are, of course, the data on which decisions about treatments we use every day are based. Most of the medicines doctors currently prescribe were tested in clinical trials a decade or more ago. Dr Ben Goldacre, the author of Bad Pharma and one of the founders of the AllTrials campaign points out that 'Over the next two years, many of the drugs in common use will come to the end of their patent life. When that happens, it may become even harder to get the information that has been withheld.' Doctors, pharmacists, regulators and researchers won’t have all the available information, leading to bad treatment decisions, missed opportunities for good medicine, and trials being needlessly repeated.
The EU legislation would mandate the reporting of summary results from clinical trials within a year of the trial’s end. As the Royal Statistical Society told us when they joined AllTrials 'It is crucially important that the results of scientific research be made publicly available and disseminated as widely as is practical, in a timely fashion. Decisions to publish should not be based on whether research findings are ‘positive’ or ‘negative.’'
An important addition not yet in the legislation but under debate is a proposal to make clinical study reports publicly available. Clinical study reports (CSRs) are long documents normally produced for marketing authorisation purposes. CSRs contain a large amount of detailed information about the methods, analysis, results and conclusions of a clinical trial – information that is needed to make and to scrutinise decisions about medicines and to assess published summary findings. A study by researchers at Germany’s Institute for Quality and Efficiency in Health Care in October 2013 found that CSRs contain significantly more of the information on patient outcomes in trials that regulators and doctors need to be able to make fully informed choices about how to treat their patients. And this is the information reviewers and meta-analysts struggle to get hold of too.
In February 2013 the pharmaceutical company GSK committed to sharing results from its clinical trials since 2000. GSK said that it will take time and resources to do it but they will do it because, as the Science and Technology Committee’s report said, that cost 'will be outweighed by the public health benefit of having a complete picture of the trials conducted on treatments currently available to patients.' The rest of the pharmaceutical industry must act in the same spirit and make transparency part of their working practices.
Since the AllTrials campaign started in January 2013, over 400 organisations and 59,000 people have joined and many of these organisations have started serious discussions about how to implement our aims. Of course we’re pleased that the Committee’s report echoed our call for all clinical trials to be registered and results reported but the progress made already has meant the Committee’s report is a little behind the times. It recommends that all trials of NHS treatments should be registered, for example, but the Health Research Authority has already gone better than that with its fantastic new recommendations. From October 30, 2013 registration of a trial in a public database before the trial begins will be a condition of ethical approval for every clinical trial conducted in the UK.
We have the prospect of significant developments to end the secrecy and make clinical trial reporting a practical reality. It’s a decisive time in Europe with the European medicines body consulting on its data sharing plans and discussions on proposed new European clinical trials laws being debated in Brussels. The UK Government must show strong leadership in Europe and hold European law makers to account to ensure they don’t let this opportunity fall.
Medicine advances because people have tested each other’s ideas, pulled them apart and asked if something could have been done better, not because everybody has secretly gone off and done things in private. But, despite the fact that hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage, change is still being blocked and slowed by bodies who say it’s hard to do, complex and hard to police. Well, sound commitments from parts of industry and the HRA’s work makes a lie of that. To produce meaningful, rapid and global change the UK Government must champion these recommendations in Europe now.
The views expressed in the Opinion section of StatsLife are solely those of the original authors and other contributors. These views and opinions do not necessarily represent those of The Royal Statistical Society.