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FDA Promotes Master Protocols to Modernize Clinical Trials

One lesson of the COVID-19 pandemic is the importance of being able to assess potential new therapies and vaccines quickly and reliably and in ways that can adapt to changing scientific evidence and public health needs. FDA has responded to these pressures by generating multiple guidance documents and policy initiatives for updating and advancing the clinical research process, including the incorporation of master protocols in research programs to facilitate the development of safety and effectiveness information for multiple test therapies in a compressed time period.

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