I am very pleased to announce the launch of a prominent campaign for access to all trial results, which we have launched this week at www.alltrials.net, with myself, Sense About Science, Sir Iain Chalmers from the James Lind Initiative (previously co-founder of Cochrane), Dr Fiona Godlee (Editor in Chief of the BMJ), and Dr Carl Heneghan (Director of the Centre for Evidence Based Medicine at Oxford).
The response so far, in a very short period of time, has been phenomenal. We have collected over 7,000 signatures already, simply from tweeting, and several extremely high profile organisations have signed up already, including:
- The Medical Research Council
- The Cochrane Collaboration
- IQWiG (the German equivalent of NICE)
- BMJ Group
- Drug and Therapeutics Bulletin
… and many more to come.
– We are campaigning for governments, regulators and research bodies to ensure that all trial results are published, in full, so that doctors and patients can identify the most effective treatments.
– We are calling for the publication of all results, and full Clinical Study Reports, for all trials conducted – both past and future – on all treatments currently being used.
– We are calling for competent legislation and regulations, with robust penalties and incentives, to ensure that this requirement is met.
– Lastly, we are calling for all universities, ethics committees and medical bodies to enact a change of culture, recognise that underreporting of trials is misconduct, and police their own members to ensure compliance.
Doctors and patients need the results of clinical trials to make informed decisions about which treatment is best. Unfortunately, at present, drug companies and researchers are perfectly entitled to withhold the results of clinical trials if they wish to do so. This is a problem, because it means that the evidence we see is skewed, usually in favour of a treatment.
The best currently available evidence shows that this problem is extremely common: overall, about half of all clinical trials have never been published, and we know that trials with negative results about a treatment are much more likely to be brushed under the carpet.
This is a serious problem for evidence based medicine: we need to have all the evidence about a treatment, in order to understand its true risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads, you could make it look as if your coin always came up heads: this is very similar to the absurd situation that we permit in medicine.
The scale of this problem is enormous. It exposes patients to unnecessary harm, because the wrong treatment may be prescribed when the evidence is distorted. It also affects some very expensive drugs. For example, governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this drug in 2009, which is 5% of the total £10bn NHS drugs budget, on one drug. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continue to withhold vitally important information about these trials from doctors and researchers even today. Some academics now suspect that the drug may be no better than paracetamol.
Many things have been tried to fix this problem, but they have all failed. Since 2008, for example, an FDA has required results of all trials to be posted within a year of completion. Howeber, no public audit was conducted, and an audit published in 2012 has now shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance. Furthmore, even if this rule had been enforced, most currently used drugs came on the market before 2008, so the trial results we need to practice medicine safely still cannot be accessed.
We believe that this situation cannot be allowed to go on.