Why the data on all drug trials must be released

http://www.theguardian.com/commentisfree/2013/sep/17/drug-trials-data-released

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Patients and researchers are finally beginning to realise that we don't know what was found in around half of all clinical trials, and we don't even know about all the trials that have been done. Serious proposals to put this right are now coming into view – global registries such as the EU Clinical Trials Register and clinicaltrials.gov, the world's largest, are talking about how to add missing data; some companies are working together to become fully transparent and today the Commons science and technology committee did their part with a report from an inquiry into clinical trials.

It contains some good things, especially on getting data from past clinical trials out from behind closed doors. 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. 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.

That's why the committee's call for the government to audit all publicly funded clinical trials since 2000 to identify gaps in registration and reporting is so important. It recommends imposing sanctions on researchers who fail to fill in gaps within a year and asks government to make sure researchers are given the resources they need to comply.

In February 2013 the pharmaceutical company GSK committed itself to sharing results from clinical trials since 2000. GSK said that it will take time and money, but that as today's report says, the cost "will be outweighed by the public health benefit of having a complete picture of the trials conducted on treatments currently available to patients." MPs have called on the rest of the pharmaceutical industry to act in the same spirit and to make transparency part of their working practices.

Since the committee launched its inquiry and the AllTrials campaign started in January, over 400 organisations and 57,000 people have joined the campaign and many of these organisations have started serious discussions about how to implement our aims. The Health Research Authority, for example, has produced fantastic new recommendations. From the end of this month 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.

It's a decisive time, with the European medicines body consulting on its data-sharing plans and proposed new European clinical trials laws being debated in Brussels. The UK government must show strong leadership in Europe and hold European lawmakers to account to ensure they don't miss this opportunity.

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, change is still being blocked or slowed by bodies that say it's too complex and hard to police. Well, today's report, commitments from parts of industry and the HRA's work give the lie to that. It's now time the government threw its weight behind the drive for complete transparency.

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