Tuesday, February 1, 2022 at 11:00 EST What is key learning? Can adaptive trials ensure quicker decision-making? Can the added value of running adaptive trials be measured?
The success of adaptive COVID vaccine programs is further spurring the popularity of adaptive clinical trial designs. Though carried out under exceptional conditions, these programs are looked to as models to speed clinical development. However, justifying the added work adaptive designs require needs accurate measurement of their value.
Adaptive designs are not procedural shortcuts in clinical development but instead offer promise of eliminating “white space” or down-time between decisions. Using adaptive designs strengthens clinical plans by reducing the risk of sub-optimal development choices, and recent FDA guidance (2019) seems sympathetic to greater employment of these techniques.
3 Key take-aways
Bruce Basson is a biostatistician specializing in clinical development plan optimization and due diligence asset valuation. At IQVIA, Bruce co-leads a team which created a technology platform called ‘Pipeline Architect’ used for optimization and valuation solutions. For 29 years, Bruce has provided statistical and strategic drug development consulting in positions at Merck, Lilly and IQVIA, designing and analyzing clinical trials over a wide range of therapeutic areas.