New petition aims for all clinical trials to be registered and reported

Posted: February 6, 2013 in Ethics, Policy, Science

An unsuspecting individual may assume that information from each and every clinical trial must be reported and made accessible. I mean, clinical trials are supposedly conducted in order to protect people, so of course all of the results, positive or negative, must be reported. Oh how sadly far this assumption strays from reality! An editorial in the British Medical Journal states, “Biased under-reporting of research has been documented for well over two decades and the evidence for it is now overwhelming.1 2 3 4 Under-reporting is research misconduct and has serious consequences.5 6 It leads to overestimates of the benefits of treatments and underestimates of their harmful effects.7 Because of this it puts patients at risk and wastes healthcare resources.”

Now a new initiative called All Trials Registered, All Results Reported is trying to end this potentially life-threatening malpractice. All Trials Registered, All Results Reported is an initiative of Sense About ScienceBad ScienceBMJJames Lind Initiative, the Centre for Evidence-based Medicine and others from research, patient groups and medicine.

You can sign their petition here.

To hear Dr. Ben Goldacre, author of the Guardian’s Bad Science column, explain why this is such an important problem that must be fixed asap go here.

From the AllTrials campaign:

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 [1].

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.

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 [2]. 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.

References:

1.  F Song, S Parekh, L Hooper, YK Loke, J Ryder, AJ Sutton, C Hing, CS Kwok, C Pang, I Harvey. Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010; Vol. 14: No. 8 http://www.hta.ac.uk/fullmono/mon1408.pdf

2.  Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373.  http://www.bmj.com/content/344/bmj.d7373

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