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Bayesian Methods for Master Protocols

As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to ensure optimal use of data and flexible trial designs.

Master protocols are used for umbrella trials, basket trials and other clinical trial designs that enable multiple therapies to be tested at once. They provide the rules for adding and dropping arms on clinical trials where standards of care might constantly be changing, thus requiring special tools for updating comparator arms, adding new therapies and so forth.

Some of the most recognized master protocols in play today include those for the STAMPEDE trial which has been enrolling for the past twenty years, the SOLIDARITY trial coordinated by World Health Organization, and the RECOVERY trial in the UK. The advent of the Covid-19 pandemic has also brought renewed attention to the REMAP-CAP Trial for pandemic response.

The desire for greater efficiencies within clinical development has begun to highlight the many benefits of master protocols. Cytel founder Cyrus Mehta, for example, gave a webinar last year on multi-arm multi-stage clinical trials, which resulted in discussion of whether FWER requirements ought to be adjusted to incentivize the efficiencies offered by master protocols. The coronavirus pandemic has also showcased the benefits of such master protocols in quickly deploying vaccines trials during complex emergencies.

Bayesian methods are particularly useful for these complex trial designs, as they enable greater flexibility and better ability to respond to the needs of the master protocol designs.

Jason Connor, President of ConfluenceStat, recently gave a Cytel webinar on the subject of master protocols and their use of Bayesian methods. Click below to watch the webinar.

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