Adaptive Clinical Trials

Master protocols and adaptive designs accelerate development with multiple successful programmes. The session covers I-SPY 2.2 in breast cancer, Lung-MAP in NSCLC, basket trials (vorasidenib INDIGO, larotrectinib NAVIGATE), umbrella trials, decentralised clinical trials, diverse patient enrolment after FDA 2024 Diversity Action Plan rule, and the regulatory landscape. Discussion addresses Bayesian adaptive designs, the comparison of adaptive vs traditional trial efficiency, platform trials (RECOVERY, REMAP-CAP), digital biomarkers as endpoints, virtual trials, and emerging adaptive enrichment strategies in oncology.