In an effort to boost scientific progress, new drug innovation, and clinical trial transparency, the U.S. Food and Drug Administration (FDA) will publish certain information from sponsor-produced clinical study reports (CSRs), beginning with documents volunteered by manufacturers following a drug’s approval, Conmmissioner Scott Gottlieb, MD, announced earlier this week.
The agency will select up to nine recently approved New Drug Applications whose sponsors volunteer to participate and post portions of the CSRs from the pivotal trials as submitted to the FDA by the drug’s sponsor at Drugs@FDA.
Shedding light on CSRs will provide more clarity on the FDA’s decision-making process, Gottlieb said. “We expect that making a CSR publicly available after a drug’s approval will provide stakeholders with more information on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process,” he explained.
FDA will post the part of the CSRs that were most important to the agency’s assessment of the safety and efficacy of the drug. “Specifically, we’ll include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies,” Gottlieb said. The CSRs will be posted on a new page on the FDA’s website that describes the pilot program in greater detail.
“Once the clinical trial transparency pilot program is complete,” Gottlieb said, “we’ll seek public feedback through a Federal Register notice and docket for public comments, and we look forward to learning more about the benefits of expanding this effort.”
Gottlieb noted the effort represented the first time that the FDA is proactively disclosing CSRs from sponsors to the public. In October 2016, the European Medicines Agency launched a program to publish CSRs and protocols from all new drug submissions, regardless of approval status. A detailed summary of the information contained in the CSR can be found at the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use website.
For more information, contact the Center for Drug Evaluation and Research’s Office of New Drugs at ClinicalSummaryPilot@fda.hhs.gov or 301-796-8686.
Author: Michael Causey