Thursday, March 14, 2013

A Call for Mandatory Publishing of Clinical Trials

Non-publication of research is a huge problem in medicine, specifically in drug trials. It's a problem that affects all of us: health care consumers and health care providers, young, old, and in between.

Of all the clinical trials that are conducted and completed, only around half get published in academic journals. Trials with positive results are twice as likely to be published as others. This is according to a systematic review conducted in 2010 by the NHS NIHR Health Technology Assessment Programme (UK).

Studies have repeatedly found Data from http://www.alltrials.net/wp-content/uploads/2013/01/Missing-trials-briefing-note.pdf
Selective publication of results is, of course, antithetical to the spirit of good science. It also has serious practical consequences. Clinicians who rely on published findings to determine which medications to dispense (and how best to manage their use) end up recommending drugs without knowing what their real effects are. As one physician, Dr. Richard Lehman, puts it: "It is a scandal that doctors like myself often prescribe treatments without knowing their true benefits and harms because research evidence from human trials has been withheld. That means that over my 35 years as a GP, I have unintentionally spent large sums of [government] money on treatments that did not work, and some patients have suffered avoidable harm. We need immediate access to all the data relating to all the drugs and devices which we use on millions of people every day."

Fortunately, there's a move afoot to get this situation corrected. All Trials Registered, All Results Reported is an initiative of Sense About Science, Bad Science, BMJ, James Lind Initiative, the Centre for Evidence-based Medicine and others aimed at getting 100% of clinical-trials research published. The group started a petition drive in January (you can sign the AllTrials petition here; and be sure to Tweet it with hashtag #AllTrials), and it has begun to get some traction in the industry. GlaxoSmithKline got behind the AllTrials campaign in February, saying it would publish all of its clinical trial data going back to the formation of GSK in 2000 when it merged with SmithKline Beecham. Roche, on the other hand, made the mistake of issuing a feel-good press release saying it supports greater transparency in clinical trials while sticking to its position of not releasing trial data.

For more on this story, or to sign the petition, go to alltrials.net, and to donate, go to http://www.justgiving.com/alltrials/eurl.axd/2fb898db34ec76479ab47c6c24a9eeb0. And please, spread the word to your social media contacts. This is a matter of importance to anyone who takes medicine.