Clinical trial transparency research reveals progress, but more to be done
The results revealed that progress has been made from the previous publication, released in 2015 – with the proportion of new drugs with all Phase 2 or 3 trials disclosed from their NDAs rising from 50% to 67% in this year’s report.
The public availability of the results from drug trials also increased from an average of 87% to 96%, 13 months after FDA approval.
This positive news was marred slightly by the only marginal improvement that was made towards the “all trials” gold-standard. This all trials data includes Phase 1 trials that were conducted in healthy volunteers. By this parameter, the median proportion of all trials with publically available results rose only a fraction from 65% to 68%.
“We created the GPS to help advance trustworthiness and ethics in the pharmaceutical sector, by setting clear ethics standards and benchmarking the performance of companies against those standards every year,” said Jennifer E. Miller, founder of Bioethics International and lead author on the paper. “This year's Scorecard shows clear corporate leaders in clinical trial transparency and industry improvement on several metrics. We hope this improvement continues year after year, because clinical trial transparency is critical for advancing innovation, respect for trial participants, and patient health.”
In terms of ranking, Johnson & Johnson and Sanofi shared first place, based on a score card given through an equal contribution of public availability of trials in patients, compliance with legal transparency requirements and patient-level data sharing.
Both companies scores 100% on their scorecards, while AbbVie, Celgene, MSD and AstraZeneca scored above the industry average. Propping up the table were Gilead, Allergan and Valeant, with all these companies scoring under 75% on their scorecards.