Interest and appetite for master protocols is growing as sponsors consider opportunities in various therapeutic areas beyond oncology. During initial discussions, most quickly recognize the potential operational and inferential benefits of a master protocol; however, as sponsors dive deeper into the details, doubt creeps in and there are a multitude of reasons expressed for not moving forward with a master protocol. Here are some common myths and the facts around them:
❌ Myth: Master protocols only work in oncology.
✔️ Fact: While master protocols started in oncology, it is a growing field with examples of platform, basket, and umbrella trials used in many other therapeutic areas, including studies on Type 1 diabetes, Alzheimer’s disease, chronic pain, and more.
❌ Myth: Master protocols are impossible to operationalize and implement.
✔️ Fact: Master protocols have been in use for over a decade. There are unique operational challenges to master protocols, but risk mitigation can help to minimize the impact.
❌ Myth: Evaluation of design characteristics is difficult or impossible.
✔️ Fact: Simulation can be used to obtain design characteristics and gain valuable insight into various challenges that may be encountered.
There are many myths around master protocols, but many of these can be dispelled. More than a decade of experience, tools, aids, and literature can help lower the steep learning curve for groups new to master protocols, though development of a master protocols requires careful cross-functional team collaboration, which may not be native to some groups.
Interested in learning more about master protocols? Watch my webinar on “Platform trials, master protocols, and the challenges in execution”:
Read more from Perspectives on Enquiry & Evidence:
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Scott Gaines on the Power of Simulation-Guided Design to Handle Increasingly Complex Clinical Trials
Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods
Embracing Innovation: Exploring the Design of Umbrella and Basket Trials
