Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
News|Articles|June 8, 2026
Master Protocols & IRT: 5 Questions Sponsors Must Ask Before Selecting a Randomisation Partner
Author(s)Jennifer Ross
Master Protocols-including platform, umbrella, and basket trials-offer significant benefits and efficiencies in drug development compared with traditional trial protocols. However, their perpetual nature, adaptive designs, and evolving requirements make randomisation inherently more complex. As a result, implementing and maintaining robust randomisation for Master Protocols can be challenging for sponsors. Selecting the right IRT provider is therefore critical. This paper outlines five essential questions sponsors should ask when evaluating IRT providers for Master Protocols, with a focus on long-term trial success, regulatory readiness, and operational resilience.
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