Master Protocols: Expanding Research, Compressing Timelines

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As an important tool in developing oncology therapies and COVID-19 vaccines and treatments, the increased visibility of master protocols has added to interest from sponsors pursuing master protocols in other therapeutic areas. “This pandemic required transparency in drug development research outcomes and collaboration between regulators and drug developers. This necessitated rapid global adaptation of innovative trial designs, such as master protocols. Clearly, drug development has shifted based on that successful model,” suggests Pat Mann, Senior Director, Regulatory Affairs, PPD. “These designs allow study teams to flex midstream to add or remove indication cohorts, drug combinations, and to conduct other investigations in response to early findings without having to create a new study design, write a new protocol, or set up additional studies,” explains Melanie Owen, Senior Director of Early Development in PPD’s Hematology and Oncology Therapeutic Unit. “What is perhaps more relevant is that the development timeline can be compressed, as seen with the COVID crisis,” continues James McCormick, Senior Director, Regulatory Affairs, “Thus empowering the sponsor with more information in a shorter timeframe to optimize their IP selection, target the therapeutic area, and deliver a meaningful clinical indication for the label.”

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Pat Mann, Senior Director, Regulatory Affairs

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Melanie Owen, Senior Director, Early Development, Hematology and Oncology Therapeutic Unit

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James McCormick, Senior Director, Regulatory Affairs
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