A new study published in BMJ Open found that for 15 drugs approved by the US Food and Drug Administration (FDA) in 2012, a median 57% of clinical trials were registered, and only 65% of trial results were publicly available. Almost half of the drugs had at least one undisclosed phase II or III trial. For the drug trials required by law to publicly report results, only two-thirds (67%) actually did.

The study assessed 15 drugs which were ranked in the “Good Pharma Scorecard”, launched by Bioethics International. GlaxoSmithKline’s meningitis vaccine MenHibrix  came top of the rankings, with 100% of its clinical trials registered, reported and published.  For tuberculosis drug Sirturo (Janssen) and renal cell carcinoma drug Inlyta (Pfizer) all of the clinical trial results were publicly available, but only around 60% of the trials were registered. At the bottom of the ranking was HIV drug Stribild (Gilead), with only 24% of trials registered and 21% of trial results available. Similarly, Sanofi publicly reported results for 22% of trials for its multiple sclerosis drug Aubagio, and only 40% of trials for its colorectal cancer drug, Zaltrap.

Clinical trial transparency fell well short of both legal requirements and ethical standards in this study. The good news is that companies lower in the rankings were interested in how they could improve their performance.  The best performing companies show that it is possible to achieve full disclosure of trials, leaving no excuse for companies failing to meet those standards.

David Korn, M.D., professor of pathology, Harvard Medical School, and author on the paper, said:

“As part of our validation strategy for the results of the study, we shared our final datasets for each drug with its sponsor to verify accuracy. Notably, all companies responded to our requests for input. Many companies scoring lower on our ranking scale were interested in ascertaining where and how they were not transparent with the intention of improving, and those who scored highly offered recommendations for maintaining best practices.”

Bioethics International and the study authors intend to continue this research and the ranking of drugs with the Good Pharma Scorecard. They will extend their work to include drugs approved in other years and sponsored by different pharmaceutical companies. Watch this space.