01.28.25 -- Selecting Adaptive And BOIN Trial Designs

CRISPR-based gene editing techniques have the potential to revolutionize the development of gene-based therapies. The importance of early collaboration between drug developers, manufacturers, and payers is becoming more evident, as it aids in the creation of meaningful clinical endpoints and the formulation of a viable market access strategy

Adaptive clinical trials differ from typical trials in their inclusion of pre-planned adaptations to the trial design without the requisite need for a formal protocol amendment. By accumulating data throughout the study, learn how alterations can be made to the original methodology.

In this webinar, panelists discuss how collaboration between therapeutically aligned teams impacts study delivery for CAR T in autoimmune disease and neurology clinics. Topics include considerations for sponsor, site, and patient stakeholders.

The codified BOIN design is preferred over rules-based designs by trials that need an uncommon toxicity threshold, more than 3 dose escalation levels, and flexibility to cohort size and backfilling. Discover which BOIN design best suits your trial needs.