The FDA wants more variations on the tests

April 13, 2022

The U.S. Food and Drug Administration has told companies that make pharmaceuticals and other pharmaceutical products to submit plans on how they can increase the number of blacks and other organizations in the country. not disclosed in medical tests, the department said Wednesday.

Although the nation and the minority population are affected by some diseases, they have often been reported in health research, the FDA said in a news release. Barriers to access include skepticism of doctors, religion, lack of knowledge of health, and lack of knowledge of medical tests.

The FDA’s development guide expects medical companies to submit “racial and ethnic analysis” to the FDA during the initial stage of development.

In order to test medications, organizations must submit an “feasibility” report during the development of the medication but not before the time they seek support or professionalism. in proposals for clinical trials, said the lead author.

The separate organization should set enrollment goals for participants from undisclosed organizations “during the early stages of health product development,” the lead author said.

To support the effort, the FDA’s Office of Minority Health and Health Equity established the Diversity in Clinical Trials Initiative to conduct public education and public awareness campaigns.

“The U.S. population has increased, and ensuring accurate national and minority knowledge in clinical trials for regulated medical products is critical to public health. ”said FDA Commissioner Robert M. Califf, MD, in a news release.

“Going forward, making a difference is more important to the FDA to train the development of better drugs and better ways to fight diseases that often affect patients. different communities. “

Califf said the FDA’s work on differentiating clinical trials is further confirmation of the agency’s support for the “Cancer Moonshot” goal of the Biden administration to work on treating cancer. cancer.

The new FDA action adds to the first guideline for the industry to improve diversity in clinical trials.

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