FDA: 2015 – 2016 GLOBAL PARTICIPATION IN CLINICAL TRIALS REPORT

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Within the past two decades, clinical research has become more global and complex, with clinical trials increasingly being conducted in countries outside the United States. Every year, CDER approves
a number of novel drugs based upon review of safety and efficiency measures in sponsor submitted clinical trial data from participants all over the world. Although the Center oversees approval of drugs to be marketed within the United States, these innovative new products come from drug development programs spanning multiple therapeutic areas, hundreds of clinical trial sites, and tens of thousands of people globally.

In recent years, there has been growing interest in stratifying different characteristics of clinical trial participants in an attempt
to better understand variability in drug response. 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. The Center has responded with the Drug Trials Snapshots program to increase transparency of the demographic data of participants in pivotal clinical trials.

Description

Within the past two decades, clinical research has become more global and complex, with clinical trials increasingly being conducted in countries outside the United States. Every year, CDER approves
a number of novel drugs based upon review of safety and efficiency measures in sponsor submitted clinical trial data from participants all over the world. Although the Center oversees approval of drugs to be marketed within the United States, these innovative new products come from drug development programs spanning multiple therapeutic areas, hundreds of clinical trial sites, and tens of thousands of people globally.

In recent years, there has been growing interest in stratifying different characteristics of clinical trial participants in an attempt
to better understand variability in drug response. 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. The Center has responded with the Drug Trials Snapshots program to increase transparency of the demographic data of participants in pivotal clinical trials.

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