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 been chosen with eight more potential volunteers. The FDA stated that those who choose to participate will have their confidential commercial information, trade secrets, and personal privacy information redacted.
Another goal to enhance transparency is to add the NCT number to the CSR materials which can direct the reviewer to the ClinicalTrials.gov webpage. The NCT number or identifier number on these CSR materials will make it easier to associate what clinical trial they are referencing and hopefully allow the ability to follow the clinical research throughout the regulatory process.
What other transparency would you like to see from the FDA? If you are a Sponsor, would you want this type of information released?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.