December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
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NCHR Comments on FDA’s OMHHE Strategic Priorities
February 28, 2020. Efforts to improve inclusion of racial and ethnic minority populations in clinical trials need to include incentives that are more effective than merely asking companies to do so. Greater diversity would, in turn, improve the generalizability of clinical trial results and provide patients and health care professionals with the information necessary to make an informed decision about which products to use for which patients.
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