In this webinar we 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.
We will illustrate these challenges using an actual phase I trial in oncology, and 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, we will address issues specific to the design of pivotal trials for registration.
