Clinical Trials

Diversity and Inclusion in Clinical Research

By Dr. David Crouse, Nebraska Cures Board President

Clinical trials are the critical steppingstone for drugs or medical devices to become available for use by health care practitioners. These products must be thoroughly tested in humans for safety and efficacy before approval by the FDA in the United States (1). Most other countries have similar processes. It can be a long process.

Beyond gender and age, humans are obviously of different racial or ethnic backgrounds. There are differences in health-related behaviors as well as socioeconomic and educational experiences. In a nutshell, people are different from each other in many ways. In clinical practice, “one shoe SHOULD not fit all” in most practice. Read more…

Pending Legislation:

Resources:

Research in Your Backyard Report – PhRMA Report on Nebraska clinical trials

Research Nebraska’s Letter to the Nebraska Congressional Delegation – June 6, 2022

Lack of Equitable Representation in Clinical Trials Compounds Disparities in Health and Will Cost U.S. Hundreds of Billions of Dollars; Urgent Actions Needed by NIH, FDA, Others to Boost Representation. – National Academies, May 17, 2022

Diversity Push for Clinical Trials Prompts House Panel Look – June 29, 2022

6 ways to bolster FDA’s guidance for diversifying participation in clinical trials – July 21, 2022