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The American Society of Clinical Oncology (ASCO) and FDA convened a small group of experts to discuss alternative trial designs as part of the Critical Path Initiative. The discussion centered on identifying problems which affect the failure rate of Phase III clinical trials, what information should be known about a product in development before Phase III trials begin and late-phase enrichment designs. See discussion points below:
Should marketing approval be granted for a targeted therapy only tested in a Phase III trial of the target population?
What are the consequences when stratified randomization on marker status is not conducted even if the overall trial is randomized? What is the effect on the sample size of the subgroup?
Are seamless Phase II/Phase III trials really Phase III trials with specific stopping rules included for futility analysis?
Subgroups comprised of ADWG participants developed consensus answers to these questions and vetted them with the entire Working Group. ASCO presented them to the FDA in the summer of 2008. These answers are now being developed into a manuscript to be submitted for publication.
Alternative Design Working Group (ADWG) Leadership:
Howard McLeod (University of North Carolina), Chair
Samir Khleif (NCI and FDA)
Michael Link (Stanford)
Richard Schilsky (University of Chicago, CALGB)
Alternative Design Working Group (ADWG) Participants:
Jeff Abrams (NCI)
Frank Balis (NCI)
J. Carl Barrett (Novartis)
Donald Berry (MD Anderson)
Susan Blaney (Texas Children’s Cancer Center)
James Doroshow (NCI)
Elizabeth Eisenhauer (NCI of Canada)
Tom Fleming (University of Washington)
Felix Frueh (FDA)
Joe Gootenberg (FDA)
Chris Kaiser (Eli Lilly)
Thian Kheoh (Biogen, Inc; currently Cougar Biotech)
Ke Liu (FDA)
Robert O'Neill (FDA)
Mark Ratain (University of Chicago)
Mark Rothmann (FDA)
Daniel Sargent (Mayo)
Richard Simon (NCI)
Sue Jane Wang (FDA)
Richard Wooster (GSK)
Tal Zaks (GSK)
Boguang Zhen (FDA)
