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Breakthroughs in science and technology are advancing innovation in more areas of medicine, providing novel treatment options for patients. The scientific community has a deepening understanding of disease and human biology, and of the enormous potential afforded through new technologies.
The same spirit of innovation is enhancing the design and conduct of clinical research. As the U.S. Food and Drug Administration observes Clinical Trials Day, we reflect on the progress made and the widespread efforts underway to advance clinical trial innovation. This progress has been possible because of clinical trial participants and their families, health care professionals, medical product developers, federal partners and the entire clinical research community.
Clinical research plays a crucial role in supporting the development of new medical products to address unmet patient needs. The FDA has several ongoing initiatives to support innovative clinical trials and protect people participating in clinical research. This includes our work through collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum.
Enhancing diversity in clinical trials is among the FDA’s top priorities to help improve the data the agency receives about the patients who may potentially use the medical products. The FDA has published a number of guidances to promote diversity and inclusion of underrepresented populations in clinical trials to help ensure the generalizability for the intended patient population, including guidances specifically addressing enrollment of children, pregnant people, older adults and underrepresented ethnic and racial groups, as well as guidances on innovative trial designs and technologies that should make clinical trials more accessible, such as decentralized clinical trials and digital health technologies.
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