Cat Hall
VP Data and Quality
Endpoint Clinical
Master protocols – single trials that explore the therapeutic effect of one or more agents with multiple hypotheses through a series of sub-studies – are meant to speed life-saving therapies to market. Because they use a common system for patient selection, logistics, templates, and data management, they offer process efficiencies over a series of individual trials. McKinsey estimates that using a master protocol cuts 12 to 15 percent out of the trial budget and shaves about 13 to 18 percent from the study timeline.1 The structure of a master protocol is particularly useful in the study of complex diseases such as oncology and in challenging rare diseases.
Yet, for all their advantages, master protocols are not only difficult to design, but also to support from a technological standpoint. The interactive response technology (IRT) must be built to accommodate randomization, drug assignment, and supply management as the protocol evolves over the course of what can easily be a decade or more of development efforts.
Designing an IRT around the Unknowns
IRTs that support master protocols must be configured to meet future requirements that are, in many respects, unknowable. So, the requirements gathering step is especially daunting; it’s a little like answering the question, “How long is a piece of string?” The process is an exercise in thinking ahead, anticipating all possibilities, and remaining flexible. The goal is to preclude the need to reconfigure the system in fundamental ways at a future date. The best approach is to:
Choosing a Vendor
It is important to work with an IRT partner who has an established track record for quality, as it is for any trial. Specifically for master protocols, the IRT vendor should, ideally, also:
While it is challenging to design an IRT to support a master protocol, it is nonetheless do-able with a team prepared to devote considerable forethought, planning, and coordination to the solution.
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