FDA Promotes Surrogate Endpoints, “Seamless” Clinical Trials
As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.
As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions. A new guidance outlines how sponsors may compress the traditional three-phase trial into one continuous, or “multiple expansion cohort study,” to reduce the time and cost involved in devising trials for early stages of multi-phase oncology research programs.
The draft guidance maps out the process for shifting from the traditional clinical trial process to a continuous, or adaptive, study to expedite the conduct of first-in-human studies for patient populations with serious diseases where no cure is available [see
FDA also is encouraging wider use of surrogate endpoints in clinical research by publishing a list of those markers that sponsors have used to gain approval of new drugs and biologics. The list was specified by the 21st Century Cures Act to facilitate medical product development. It provides information on surrogate endpoints that have supported market applications, as well as those utilized as primary endpoints in trials, but not as the basis for filing an NDA or BLA [see
FDA commissioner Scott Gottlieb heralded the seamless trial approach as a way to avoid costly and long delays between the end and start of clinical study phases [see
Jill Wechsler is the Washington Correspondent for Applied Clinical Trials.
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