Officials in the Food and Drug Administration (FDA) and in the U.S. Senate are talking about adaptive clinical trials, as a new approach to reviewing new drugs in the U.S. market. Science magazine's Kelly Servick reported on recent exchanges made during the U.S. senate confirmation of new FDA director Scott Gottleib. In his confirmation hearing, Gottleib and several U.S. Senators discuss the merits and potential of adaptive clinical trials. The piece in Science goes on to gauge sentiment towards adaptive trials within the scientific community, and in doing so, the piece cites a new study conducted by Michael D. Fetters, M.D., M.P.H., M.A., professor, and Timothy Guetterman, Ph.D., assistant professor. Their ADAPT-IT trial, published in Trials, was designed to gain an understanding of attitudes towards adaptive trials among "trial community" stakeholders--clinicians, preclinical scientists, and biostatisticians. The study utilized a convergent mixed methods design, integrating survey and focus group data. The trial was a collaboration between U-M Departments of Family Medicine, Emergency Medicine, and Neurology, as well as investigators from UCLA and the University of Texas.
Read the Science article and find the full-text ADAPT-IT trial in BioMed Central.
Discover the latest mixed methods research from the Department of Family Medicine.