|Clarity Necessary for Clinical Trials|
Ben Goldacre and Sense About Science launch petition for inclusive trial data
Over half of all clinical trials never publish results; some have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily on people and animals.
Despite years of commitments to openness on clinical trial results, governments, regulators and research bodies have failed to take decisive action. Growing concern about that lack of progress has led patients, the public and health professionals to come together and call for immediate action. A public petition opens today at www.alltrials.net. It is an initiative of Bad Science, Sense About Science, BMJ, James Lind Initiative and the Centre for Evidence -based Medicine.
It calls on responsible bodies to ensure that all trials past and present, for all drugs in current use, are registered; and that the full methods and the results are reported.
In particular, the European Medicines Agency needs to take action. The EU Clinical Trials Regulation is currently before the European Parliament with deadlines for amendments in mid-February. The Regulation does not contain measures to ensure comprehensive registration and reporting of trials relating to drugs and practices in current use.
An editorial in the BMJ today spells out that academics as well as companies need to report the results of their trials. Editor in Chief Fiona Godlee calls on both industry and academia to clean up their act and invites BMJ readers to add their voice to the petition at www.alltrials.net: “The evidence that much research goes unreported is overwhelming, putting patients at risk and wasting healthcare resources.”
Tracey Brown, Director, Sense About Science: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements. We expect doctors and researchers to have access to the best available evidence, not half of it. Government and regulators must listen to what the public thinks about this. It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future.”
Ben Goldacre: “This problem has been dodged for too long. 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. By signing the AllTrials petition you can show governments, regulators and research bodies how much this matters, and why they need to act now. Industry and academics must share all trial results: without this information, doctors are misled, and patients are harmed.”