We rely on clinical trials in medicine, but companies and researchers are able to withhold results wherever it suits them: this breaks evidence based medicine. The best available systematic review evidence estimates that around half of all trials for the treatments we use today have not been published: you can read the details on this problem, and the flawed efforts to remedy it, here.
We decided that something needed to be done, and so we set up www.alltrials.net, with Sense About Science, the BMJ, Sir Iain Chalmers (co-founder of Cochrane) and the Centre for Evidence Based Medicine in Oxford. Since then the campaign has snowballed. We have been joined by groups as diverse as MRC, the Wellcome Trust, IQWiG (the German NICE), NPA (the US doctors body) and many more. Read the rest of this entry »
GSK have just this minute announced that they are signing up to the alltrials.net campaign.
This will be written in a hurry. Briefly: the results of clinical trials have been routinely withheld from doctors and patients throughout medicine, and this problem has not been fixed. The www.alltrials.net campaign is asking for all trials to be registered, for all summary results to be reported, and for full Clinical Study Reports to be made publicly available. CSRs are important, because it is now clear that brief summaries about trials (such as academic journal articles) can be incomplete or misleading. Last Friday I met with Andrew Witty, the head of GSK, to discuss these concerns, and it was clear that they’ve spent a lot of time thinking about these issues.
I couldn’t be any happier. This is huge, and internationally huge. GSK have made a commitment to post CSRs online. Read the rest of this entry »
There is a new EU Clinical Trials Regulation currently passing through parliament in Brussels. It is currently in draft form, and riddled with holes: essentially it allows companies and researchers to withhold trial results, and play fast and loose with analyses. These problems are best documented in the BMJ by one of the co-founders of Cochrane:
The EU lead legislator (or “rapporteur”) on this bill is Glenis Willmott. She is a Labour MEP from the UK, and well-known to those in public health for her battles with the tobacco industry in Europe. Patients around the world are very fortunate that she has been chosen for this positon on clinical trials, and I am very pleased to say that her office have just this afternoon issued a press release on trials transparency. It is very clear that she will be working hard to fix this broken legislation, and her initial report on the draft Regulation demonstrates a clear recognition of problems that have been neglected for too long. Read the rest of this entry »