New report shows evidence of poor clinical trial data disclosure in FDA applications

12 November 2015

Only two thirds of clinical trials per drug were disclosed in supporting new drug approvals in 2012, according to a new report from non-profit Bioethics International.

In addition to this, it found that almost half of all reviewed drugs had at least one undisclosed Phase II or III trial. The study evaluated clinical trial registration, reporting and publication rates for 15 new drugs approved by the US Food and Drug Administration in 2012 by legal requirements and ethical standard. Researchers found wide variation in practices between drugs.

While three of 10 companies – GlaxoSmithKline (LSE: GSK), Johnson & Johnson (NYSE: JNJ) and Pfizer (NYSE: PFE) – reported all clinical trial results for at least one of their reviewed drugs, Gilead (Nasdaq: GILD) was the lowest-scoring company, disclosing just 21% of the trial results for its drug Stribild.

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