The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
Every year, CDER approves a number of novel drugs based upon review of safety and efficiency measures from sponsor submitted clinical trial data. Participation in these clinical trials has varied greatly, with some trials having fewer than ten patients to others including several thousand. In recent years, the representation of certain subgroups such as women and people of racial minority groups, has become of greater interest to the general public. As part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA 907), the U.S. Congress required the U.S. Food and Drug Administration (FDA) to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on demographic factors such as sex, age, and race. Recognizing the lack of easily accessible information about participation in drug trials, CDER piloted a new transparency initiative called the Drug Trials Snapshots.
Snapshots are data posted online in a standardized format after approval of a novel drug that is either a New Molecular Entity (NME) or original biologic (BLA) product. They show who participated in the pivotal clinical trials used to approve the drug and stratify the data by sex, race, and age subgroups. Further, the Snapshots provide statements on whether there were any observed differences in safety and efficacy by demographic subgroups at the time of approval. Since January 2015, CDER has been publishing a Drug Trials Snapshots for each novel drug approved within a month of the official approval date.
Our Summary Reports are another commitment to enhancing transparency and better understanding of the drug development process. The report summarizes the first two years of the Drug Trials Snapshots program and is broken down by calendar years 2016 and 2015. Each calendar year provides an overall average of each demographic group followed by a more detailed summary table of the percent representation of sex, race, and age per clinical trial. Since the launch of the Drug Trials Snapshots, over a quarter million people have visited the website.
To view the Summary Reports, please visit: Drug Trials Snapshot.