FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Study Finds Mixed Results for Drugmakers’ Disclosure of Clinical Trial Results

Nov. 19, 2015

Results were mixed for drugmakers’ disclosure of clinical trial results, according to a new study from Bioethics International.

The study evaluated 15 drugs approved by the FDA in 2012 and found that only two-thirds of clinical trials per drug were disclosed. Almost half of the reviewed drugs had at least one undisclosed Phase 2 or 3 trial.

Some companies were better than others at reporting full trial results. GlaxoSmithKline, Johnson & Johnson and Pfizer all shared full trial results for at least one of their drug candidates, the report says.

Which companies were the worst offenders? According to the study, Gilead Sciences only reported 21 percent of trial results for its HIV treatment Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate). Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) also ranked low for transparency.

Sanofi defended its record of registering trials — including those for Aubagio and Zaltrap (ziv-aflibercept) — on public databases, as well as publishing results on its website, in medical journals and at medical congresses. The company said that it supports the Pharmaceutical Research and Manufacturers of America’s Principles for the Responsible Sharing of Clinical Trial Data.

Bioethics now is expanding its look at clinical trials transparency into an annual, ranked Good Pharma Scorecard, which will evaluate firms and new drugs based on clinical trial disclosure, human rights and other ethical practices related to R&D.

Gilead did not respond to a request for comment by press time.