Thursday, 31 October 2013

Scientists voice fears over ethics of drug trials remaining unpublished

Almost a third of large clinical trials in the US still not published five years after being finished, scientists write in BMJ.

Drug companies and other organisations that carry out clinical trials are violating their ethical obligation to the people who take part by failing to publish the results, scientists will argue on Wednesday.

Almost one in three (29%) large clinical trials in the United States remain unpublished five years after they are finished, according to scientists writing in the British Medical Journal. Of those, 78% have no results at all in the public domain.

The scientists calculate about 250,000 people took part in the unpublished trials and have therefore been exposed to all the risks involved in research without the benefits to society they were led to believe would ensue. This "violates an ethical obligation that investigators have towards study participants", say Christopher Jones from the Department of Emergency Medicine, Cooper Medical School of Rowan University, New Jersey, and colleagues. They call for additional safeguards "to ensure timely public dissemination of trial data." Read more here.

Article cited: Jones CW ,Handler L ,Crowell KE ,Keil LG ,Weaver MA ,Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104

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