Increasing Clinical Trial Enrollment; Comments Requested
On January 13, 2009, the FDA published a notice seeking comments on issues related to the enrollment of certain populations in clinical drug trials. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires the FDA to report to Congress on best practice approaches to increasing participation of elderly populations, children, racially and ethnically diverse communities, and medically-underserved populations in clinical drug trials. FDA requests comments from medical product manufacturers, IRBs, patient groups, researchers, and other interested parties on possible approaches to increasing participation of these groups in clinical drug trials. Comments will be accepted until February 27, 2009.
