FDA enhances the transparency of clinical trials

Ashton Steinhagen, lead clinical research associate, IMARC When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic.  Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program. In this pilot program, a group consisting of participants with nine new drug applications that had been recently approved and consist of various ranges of disease will work with the FDA to provide clinical study reports (CSRs).  Normally, the FDA will release summaries, illustrating assessment of the data, labeling, and other efficacy used to support approval; however, these reports usually are not cohesive.  The goal of the new pilot program and use of the CSRs will be to provide more transparency into the approval process, allowing the general public and physicians a more thorough background into the decision-making process of the FDA. These CSRs may contain protocols and amendments, study summaries of the results, and the statistical plan and/or analysis.  According to Janet Woodcock, who released a follow-up statement on 19 March 2018, the first participant had b...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news