Adaptive By Nature: Modern Tools For Modern Trial Designs

By Cal Collins

Adaptive platform trials (APTs) are reshaping clinical research by enabling multiple therapies to be tested simultaneously under a single, flexible protocol. Unlike traditional trials, APTs adapt in real time, adding or dropping treatment arms, modifying randomization, and seamlessly transitioning between trial phases. This results in faster insights, improved patient safety, and reduced resource use. Pioneering studies like REMAP-CAP, RECOVERY, and I-SPY 2 have proven APTs’ impact, particularly in urgent therapeutic areas like oncology, ALS, and Alzheimer’s.

I-SPY 2, led by Quantum Leap Healthcare Collaborative, stands as a model of this approach in breast cancer research, having evaluated 25 therapies with several advancing to accelerated FDA approval. OpenClinica powers this groundbreaking trial, providing a dynamic platform that supports rapid protocol changes, automated data capture, and seamless electronic health record (EHR) integration. Its modular, interoperable architecture enables real-time adaptations in eligibility criteria, randomization, and consent processes.

APTs’ versatility—spanning design, randomization, and operational adaptations—demands advanced technology that legacy EDC systems can’t provide. OpenClinica delivers the flexibility and scalability needed to manage complex, evolving trials. As the life sciences industry embraces faster, smarter, patient-centered research models, OpenClinica remains at the forefront, supporting adaptive trials that bring innovative treatments to patients sooner.