FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi and J&J Rank Highest in Clinical Trial Transparency: Study

Dec. 8, 2017

Drugmakers have improved at clinical trial transparency compared to 2015, with Sanofi and Johnson & Johnson sharing first place in a transparency ranking sponsored by Bioethics International.

Researchers analyzed disclosures for 505 trials sponsored by 11 drugmakers for 19 drugs approved by the FDA in 2014. They found that public availability of results for each drug improved, and the median disclosure rate of trials conducted in patients for each drug increased from an 87 percent to 96 percent median.

Researchers found disclosure rates for trials in patients of 65 percent upon FDA approval, but that they had increased substantially by three months post-approval to 85 percent. Results are publicly available in some form at time of approval for a median of 45 percent of trials per drug, according to the study.

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