Today is International Clinical Trials Day, held on May 20th in honor of George Lind, the famous Scottish physician who began one of the world's first clinical trials on May 20th, 1747. This trial discovered that vitamin C deficiency was the cause of scurvy. While it and the other life-saving trials that have been conducted in the last two hundred and sixty seven years are surely worth celebration, International Clinical Trials Day is also a time to reflect on the problems that plague the clinical trials system. In particular, the lack of reporting on nearly half of all clinical trials has potentially deadly consequences.
The AllTrials campaign, launched in January 2013, aims to have all past and present clinical trials registered and reported. From the AllTrials campaign website:
Doctors and regulators need the results of clinical trials to make informed decisions about treatments.
But companies and researchers can withhold the results of clinical trials even when asked for them. The best available evidence shows that about half of all clinical trials have never been published, and 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 because we need all the evidence about a treatment to understand its risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, 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, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.
It also affects some very expensive drugs. Governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this one drug in 2009, which is 5% of the total £10bn NHS drugs budget. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continues to withhold important information about these trials from doctors and researchers. So we don’t know if Tamiflu is any better than paracetamol. (Author's note: in April 2014 a review based on full clinical trial data determined that Tamiflu was almost entirely ineffective.)
Initiatives have been introduced to try to fix this problem, but they have all failed. Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance. In any case, since most currently used drugs came on the market before 2008, the trial results that are most important for current medical practice would not have been released even if the FDA’s law was fully enforced.
We believe that this situation cannot go on. The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials – past, present and future – on all treatments currently being used.
We are calling on governments, regulators and research bodies to implement measure to achieve this.
And 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.
You can learn more about the problem of missing clinical trial data in this brief. AllTrials also provides slides on this issue to incorporate into talks and presentations as well as a petition you can sign.