FDA Releases Clinical Trial Data In Drug Trials Snapshot Pilot Program
By Cyndi Root
The Food and Drug Administration (FDA) continues its mission to make clinical trials more transparent with the launch of a pilot program called Drug Trials Snapshot. The federal agency publicized the new webpage via email announcement, the Federal Register, and its News & Event page. The webpage aggregates information from clinical trials on FDA approved drugs. Information includes participant demographics, trial design, and results sorted through sex, age, and race/ethnicity filters.
John J. Whyte, M.D., MPH, Director at the FDA’s Center for Drug Evaluation and Research, said in a published conversation, “Even though this information has been publically-available in various formats, it has never been gathered in one centralized location. People can actually go to a snapshot on our web site and see the number and types of men and women who have been involved in clinical trials.”
Drug Trials Snapshot
The FDA initiated the new program in accordance with the 27 action items in its “2014 Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” published in August. The FDA is phasing in the Drug Trials Snapshot with six new molecular entities (NMEs) that were approved between May and June 2014. The agency intends to post a Snapshot for every NME and biologic it approves, starting in 2015.
Before it rolls out the complete program, the FDA is seeking input from sponsors, consumers, and healthcare providers on the usability of the webpage. Interested parties can comment on the format and content of the Snapshots page, and the FDA will revise the page to reflect feedback.
Each Snapshot covers a single drug. It includes a demographic breakdown of sex, age, and ethnicity and provides efficacy and safety results sorted demographically. The FDA states that the Snapshots are easy to understand and terminology is explained so that consumers can understand.
Six NMEs To Start
According to the FDA, six NMEs are included in the pilot, however one of the NMEs has two indications (Entyvio in Crohn’s Disease and Ulcerative Colitis). Also included are Dalvance and Sivextro in skin infections, Jublia in fungal infection, and Zontivity in heart attack or peripheral arterial disease. In the Zontivity Snapshot, the FDA states that the agent was similarly effective in men and women; non-Caucasians were not well represented; and Zontivity was effective in all age groups. Women and older patients had a higher rate of bleeding.