FDA Aims to Improve Access to Clinical Trial Info for New Drugs

To better enhance transparency around FDA drug approval decisions, the agency is launching a pilot program aimed at improving provider access to key information related to new drugs, according to a statement.

After approvals of new drug applications (NDAs), the FDA releases certain information used during the reviewing process of the NDA, including summaries written by medical reviewers, proposed labeling or other requirements, and other relevant data on the product’s safety and efficacy. In the statement, FDA Commissioner Scott Gottlieb, MD, acknowledged that this format may make it difficult for the public to extract the detailed clinical evidence that supported the approval decision. As a result, he announced that the agency intends to post portions of clinical study reports (CSRs) pertinent to a clinical trial that contains the most relevant to the FDA’s assessment of the drug’s safety and efficacy. CSRs are company-generated summaries that contain details about the bottom line information on the methods and results of a clinical trial.

“Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations,” Dr. Gottlieb said in the statement.

The pilot, which begins this month, will include up to 9 NDAs across a range of disease areas. The FDA will post the CSRs on a new web page on the FDA’s website after the drug is approved. These parts will include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies.

The agency also plans on adding the ClinicalTrials.gov identifier number to make it easier to associate the clinical trial listings to FDA communications about specific drugs, according to the statement.

Reference

FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592566.htm?utm_campaign=01162018_Statement_Transparency%20of%20clinical%20trial%20information&utm_medium=email&utm_source=Eloqua. Accessed January 16, 2018