Master Protocols Demand an RTSM Master Plan

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Term to Know:

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Master protocols

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Master protocols are single trials that explore the therapeutic effect of one or more agents with multiple hypotheses through a series of sub-studies. Because they use a common system for patient selection, logistics, templates, and data management, they offer process efficiencies over a series of individual trials, which can speed life-saving therapies to market.

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McKinsey estimates that clinical trials using a master protocol cut 12–15% out of a trial budget and shave 13-18% percent from a study timeline. The structure of a master protocol is particularly useful in the study of complex and rare diseases. 

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Yet, for all their advantages, master protocols are not only difficult to design, they are difficult to support from a technological standpoint. The RTSM system must be built to accommodate randomization, drug assignment, and supply management as the protocol evolves over the course of a decade or more of development efforts. 

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Designing your RTSM System Around Unknowns

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RTSM systems that support master protocols must be configured to meet future requirements that are, in many respects, unknowable. The requirements gathering step can be especially daunting as the process is an exercise in thinking ahead, anticipating possibilities, and making decisions while remaining flexible. The goal is to limit the need to reconfigure the system at a future date. 

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Some steps in this design process include: 

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• Thinking through the system requirements at least six weeks in advance. Building the RTSM system for a master protocol is inherently more complex than for a single study and naturally takes more time. 

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• Approaching the challenge holistically with the help of a cross-functional team that includes all eClinical partners. 

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• Defining which elements of the protocol will be variable, and which will remain static. For example, a core set of questions used to screen patients may remain the same across all sub-studies and for the life of the protocol. Dosing, on the other hand, might be quite variable. 

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Then, for each identified variable, establish the outer limits of the range. Dosing, for example, might be confined to 10 – 100 mg. This step dovetails with the creation of the statistical analysis plan.

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Will patients be able to move between studies? How will patients who are eligible for more than one study be assigned? Leveraging a team that has assisted in running clinical trials for over a decade is the most efficient way to supply the investigational and comparator products across the sub-studies. We can help you to determine, for example, if it is feasible to pool supplies, or if each study must have its own resupply algorithm.

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Endpoint experts can work with you to determine the basic rules that will govern randomization. 

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It is vital to work with an RTSM partner who has an established track record of security, stability, and trust. For developing master protocols, your RTSM partner should also:

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• Offer an extremely flexible and feature-rich system, one that can be configured within the established parameters, and a team that can offer continuous and flexible support throughout the duration of a trial, accommodating amendments and mid-study adjustments.

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• Deliver extensive control for administrative functions to the sponsor. The sponsor might, for instance, be given the ability to manage cohorts, including setting up new cohorts, deciding how many patients will be randomized to each, and establishing the criteria and dosing.

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• Demonstrate a track record for operational excellence and ongoing investment in the platform. 

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• Operate quietly and collaboratively behind the scenes as your hidden advantage.

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While it is challenging to design your RTSM system to support a master protocol, working with a team that has deep industry experience and a constantly evolving platform can help you reach your trial endpoint successfully. To learn more, contact us today.

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