Why Should You Attend:

Adaptive designs for clinical trials have attracted a lot of attention recently because they allow the trialist to start a study with less information than is typically needed for a successful trial. Typically, information about optimal endpoints, effect size, optimal inclusion and exclusion criteria, etc., are gathered from a pilot or feasibility study and used to design the pivotal trial.

Adaptive designs allow these two studies to be combined into a single trial – saving the sponsor company time and money and enhancing the chances for success – with one or more “looks” at the data to adjust the design as necessary. The adjustments can include the sample size, the hypotheses tested, the endpoints evaluated, the patient subgroups included, etc. FDA has been receptive to these designs as they come under pressure to increase the competitiveness of US companies by decreasing time to market.

This webinar will help you identify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

Areas Covered in the Seminar:

Definition of “adaptive design”.
Benefits.
“Legal” adaptations and when to use them.
Regulatory acceptance.
Details on how adaptations work.
Examples.
Q & A.