Implementing Adaptive Trials: Operational Considerations

June 12, 2014

IDDI organized a webinar on Implementing Adaptive Trials: Operational Considerations.

  • In this webinar the speakers discussed 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.
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Implementing Adaptive Trials: Operational Considerations

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  • In this webinar the speakers discussed operational challenges that are of key importance in adaptive trials.
  • These challenges were illustrated using an actual phase I clinical trial in oncology, and the speakers argued 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 were addressed.

Speakers:

  • Marc Buyse, Sc.D, Founder, IDDI
  • Linda Danielson, M.S., Chief Operating Officer, IDDI
Presentation of the Webinar: Adaptive Trials: Operational Considerations

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