It's no secret that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately but there is no real accounting for the consequences of unpublished evidence.
In the editorial, Dr. Richard Lehman from the University of Oxford and BMJ Clinical Epidemiology Editor, Dr. Elizabeth Loder, call for more regulation and full access to raw trial data to allow better understanding of the benefits and harms of many kinds of treatment.
A study by Beth Hart and colleagues finds that including unpublished data in published meta-analyses of drug trials often changed their results. They argue that access to full trial data is needed to allow drugs to be independently assessed. Two further studies showed poor adherence to requirements for mandatory trial registration and timely sharing of results. Ross and colleagues said that fewer than half of US National Institutes of Health funded trials are published in a peer reviewed journal within 30 months of completion, while Andrew Prayle and colleagues find that only 22% of trials subject to mandatory reporting had results available within one year of completion.
"When the word 'mandatory' turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear," write Lehman and Loder. Other studies highlighted the difficulties researchers face when they try to assess the true harms and benefits of common interventions.
Opinions vary but Lehman and Loder use hot button verbage and argue that non-publication is instead 'concealment of data' and "a serious ethical breach" and that clinical researchers who fail to disclose data "should be subject to disciplinary action by professional organisations."
They conclude: "These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine."
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