Bioethics group: Gilead, Sanofi flunk the clinical trial transparency test
- Almost half of drugs reviewed in 2012 had undisclosed phase 2/3 data, according to Bioethics International. The non-profit published an article in BMJ Open analyzing the transparency of biopharma companies in reporting clinical trial data on drugs submitted for regulatory review.
- Overall, one-third of clinical trial data was never published.
- According to the report, Gilead fared the worst in terms of adherence to the legal and ethical standards associated with disclosure of clinical trial data. The team of bioethicists found that Gilead only provided 21% of the clinical trial data on Stribild, its four-in-one fixed-dose combination medication used to treat HIV.
Despite a series of initiatives designed to promote transparency, including a 2007 law in the U.S. which makes failure to register clinical trial results illegal, the goal of complete transparency remains elusive.
Researchers and ethicists continue to push for better tracking of company's trial data. This latest round of research has found that many companies, with Gilead topping the list, fall short of transparency goals—often woefully short. Merck also fared poorly, with a dismal record of reporting clinical trial data supporting the approval of its multiple sclerosis (MS) drug Aubagio.
The oversights do not appear intentional as all companies were willing to submit information for review upon request. In fact, companies expressed interest in knowing where they had transparency deficiencies and how they might improve them. This response bodes will for the transparency movement in general—as well as researchers, physicians and patients.