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Speakers:
Marc Buyse, Sc.D., Founder, IDDI
Linda Danielson, M.S., Chief Operating Officer, IDDI
In this webinar the speakers will discuss operational challenges that are of key importance in adaptive trials:
The needs:
to validate the design through simulations,
to control the trial centrally,
to collect and analyze key data rapidly,
to preserve the trial blinding and integrity,
and to document all important adaptive decisions taken.
These challenges will be illustrated using an actual phase I trial in oncology, and the speakers will argue that the issues can be addressed through:
proper planning,
choice of experienced vendors and independent groups (coordinating center and DSMB),
statistical teams with adequate expertise and experience with the design chosen,
recourse to efficient computer technology (IWRS, EDC, automated emailing),
and oversight by a specialized team.
Finally, issues specific to the design of pivotal trials for registration will be addressed.
