This webinar will provide a deep dive into what questions drug developers can ask themselves to determine whether their development plan is a candidate for incorporating some aspects of an adaptive design and if the plan may be better suited to an early or late phase adaptive design.
TORONTO (PRWEB) June 15, 2020
Adaptive designs are a wide umbrella for any design which changes during a trial, but in a pre-specified manner. They may allow for earlier go/no-go decisions and the ability to potentially answer more questions than traditional drug development. For example, testing additional small population subgroups (or tumor types) to be included in a basket trial could result in the approval in any or all groups when those smaller populations may have been excluded in a standard trial. Adaptive designs could include the use of a historical control, borrowing across treatment arms and/or tumor types, adjusting the sample size during the trial, dropping unfavorable arms and/or stopping early due to effectiveness.
Adaptive designs used to have a stigma with some designs, even being considered not “well-understood.” However, regulatory agencies and drug developers are starting to see what fruits these designs may bear, as examples of success include master protocols/platform/umbrella trials, the PREVAIL II Ebola trial and other published studies. These results of interaction with the FDA through the Complex Innovative Design program have become available to the public.
This webinar will provide a deep dive into what questions drug developers can ask themselves to determine whether their development plan is a candidate for incorporating some aspects of an adaptive design and if the plan may be better suited to an early or late phase adaptive design. It will offer an expanded understanding of exactly what it means to run an adaptive trial.
For more information or to register for this event, visit Optimizing Clinical Trials Using Adaptive Design: Early Alignment for Success.
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