Innovations in Accelerating Dose Finding Designs with Backfilling

Music City Center 

Dose finding studies are used to determine the optimal dose for a treatment in early clinical development. In these studies, ad hoc backfilling occurs to increase the sample size for investigating key doses of interest. Recently, formal frameworks for backfilling have been developed to improve upon ad hoc backfilling for dose finding designs for complete cohorts. We have worked to improve the flexibility of these designs to make dose assignment decisions with partial information to handle late-onset toxicity or fast accrual. We compare our new innovation with previous methods to demonstrate the benefits of formal backfilling without large increases in study duration, as well as demonstrate how such designs can be integrated into a seamless framework.

Dose Finding

Backfilling

Clinical Trials

MTD

Dose Escalation

Seamless Design 

Biopharmaceutical Section