Unpublished trial results are "ethical failure"

Michael Cook
9 Nov 2013
Reproduced with Permission

Nearly 300,000 people who participated in clinical trials have been exposed to harm without any personal or social benefit, according to research published in the BMJ. An analysis of 585 large, randomized clinical trials registered with ClinicalTrials.gov found that 29% had not been published in scientific journals and that about 78% of these had no results available on the website.

Non-publication of clinical trials is a controversial issue. Industry-funded clinical trials - such as those paid for by pharmaceutical companies - have come under fire on allegations that they are often not published if results are unfavourable.

The authors say that non-publication constitutes "a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation". They point out that ethical standards such as the US government's "Common Rule" and the Declaration of Helsinki stress the importance of making results available. "When trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized."

The study authors examined the outcomes of 585 large, randomized trials with at least 500 participants registered with ClinicalTrials.gov and completed before January 2009. (ClinicalTrials.gov is a website that provides easy access to information on clinical studies on a wide range of diseases and conditions.)

Of these, 29% had not been published by November 2012. Non-publication was more common among trials that received industry funding (32%) compared to those without industry funding (18%).