Enter to open, tab to navigate, enter to select
FDA Releases Summary Report of Drug Trials Snapshots for 2015 and 2016 (US)
Practical Law Legal Update w-006-5137 (Approx. 2 pages)
FDA Releases Summary Report of Drug Trials Snapshots for 2015 and 2016 (US)
by Practical Law Life Sciences
| Published on 22 Feb 2017 • USA (National/Federal) |
The FDA released a summary report on the first two years of the Drug Trial Snapshots program.
On February 13, 2017, the FDA released a summary report of the Drug Trial Snapshots program, covering 2015 and 2016. Under Section 907 of the Food and Drug Administration Safety and Innovation Act, the FDA is required to, among other things, report on certain clinical trial participant demographics and differences in safety and effectiveness data between subgroups. Since January 2015, the FDA's Center for Drug Evaluation and Research (CDER) has published the Drug Trial Snapshots program to meet this obligation.
Within a month of FDA approval of a novel drug or biologic, CDER posts online "snapshots" of the pivotal clinical trials that supported approval. The snapshots include any observed differences in safety and efficacy between demographic subgroups that were reported in the marketing application.
According to the summary report, in 2015:
- 105,826 subjects participated in clinical trials of 45 approved novel drugs or biologics.
- 40% of subjects were women, 79% were white, 12% were Asian, 5% were African-American, and 37% were 65 years or older.
- There were five mental health, 14 oncology, and ten cardiovascular drug approvals.
In 2016:
- 31,468 subjects participated in clinical trials of 22 approved novel drugs or biologics.
- 48% of subjects were women, 76% were white, 11% were Asian, 7% were African-American, and 21% were 65 years or older.
According to the report, over 235,946 people have visited the Drug Trial Snapshots website since its launch.