FDA to begin releasing clinical study reports in pilot programme

The US Food and Drug Administration (FDA) has announced it will disclose clinical study reports (CSRs) in a pilot programme to begin this month.12 Participation in the pilot will be voluntary for sponsors, include up to nine recently approved drug applications, and is limited to CSRs for the key “pivotal” trials that underpin drug approval.

Declaring that “transparency can be a powerful tool for innovation,”3 FDA commissioner Scott Gottlieb also argued the public CSRs would help streamline the FDA’s evaluation of drug applications and “create a more efficient review process.”4

The announcement, made on 16 January at a transparency forum led by Johns Hopkins School of Public Health, thrusts the regulator into an activity senior officials have in recent years resisted, arguing that data sharing was an activity best left to the companies that own the data, not middlemen like the FDA.

Historically, the agency’s position has been that laws such as the Trade Secrets Act prohibit it from releasing trial data,5 and there have been only a handful of cases where the FDA has released CSRs, sometimes in response to …