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.
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.
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.
Some steps in this design process include:
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.
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.
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:
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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