ISPE 2026 workshop

Relapsed / refractory multiple myeloma CAR-T — digital twins for a hybrid control arm

Recruitment is slow in a 1:1 randomised Phase 2b/3 CAR-T trial, and the sponsor has 500 curated digital twin control candidates on hand. The exercise works through whether a hybrid control arm beats replacing randomisation outright.

Hoa Le, MD, PhD, UNC-Chapel Hill; Jennifer Briley Christian, PharmD, MPH, PhD, FISPE, Evinexus, USA

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