Innovation topics listed on this page represent
key topics in today's pharmaceutical drug development. The choice
of topics was guided by recently published regulatory guidelines
as well as other regulatory documents, for example, the
FDA
Critical Path Opportunities list. Each topic is managed by
an Advisory Board comprised of thought leaders/experts from the
industry, academia and regulatory agencies.
Flexible approaches to designing clinical
trials, including adaptive dose-finding methods, seamless Phase
II/Phase III designs, sample-size modification methods and other
adaptive designs in late-phase trials.
Multiplicity issues arising in clinical trials
due to multiple dose-control comparisons, subgroup analyses, endpoints
and objectives.
Cardiac safety assessments in clinical trials
(with emphasis on repolarization abnormalities such as QTc prolongation).
Analysis of longitudinal measurements and
incomplete data in clinical trials.
