REMAP-CAP master protocol has lessons for studying drug cocktails
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The U.K.’s REMAP-CAP master protocol is poised to teach drug developers a way to cut through the mess of individual trials for drug combos in diseases where drug cocktails are all but inevitable. If successful, it will also serve as one more salutary lesson of the broad-reaching benefits of preparing for pandemics during the good times.
The case for master protocols is already receiving a significant boost during COVID-19, with nine adaptive master protocols under way already, and the design selected as the major vehicle for expediting testing by industry consortia such as COVID R&D (see “COVID R&D Consortium Launches I-SPY Adaptive Trial with Quantum Leap”).
However, REMAP-CAP is the only one with a multifactorial design, which means it studies drug cocktails, rather than evaluating multiple individual treatments side by side. As such, it’s designed to answer a much broader range of questions.
“The protocol is designed to explore the effect of treatment