Nancy Geller, Ph.D., NIH/NHLBI
November 10, 2009 @ 3:30 pm - 4:30 pmLocation: BRB - 251
Biostatistics
TITLE: Confirmatory Clinical Trial Designs for Biomarkers
With the accelerating pace of biomedical discoveries and
the drive for personalized medicine, many randomized clinical
trials are being proposed to confirm the validity of a biomarker
as predictive of the response to therapy. How will we decide
which trials to undertake and create designs that are most
efficient? We discuss the level of evidence required prior
to undertaking a confirmatory trial of a hypothesized predictive
marker. Designs of trials to confirm that a marker is predictive
are reviewed and cardiovascular examples are detailed. Use
of unconventional endpoints and new analysis methods are
provided to illustrate how to make such clinical trials more
efficient.
