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  • Washington Highlights

    AAMC Comments on Accelerating the Decentralization of Clinical Trials


    Daria Grayer, Director, Regulation and Policy
    For Media Inquiries

    The AAMC submitted a letter on May 12  to the National Center for Advancing Translational Sciences (NCATS) in response to a request for information (RFI) on ways to accelerate the decentralization of clinical trials (DCTs). NCATS is especially interested in “gaining a deeper understanding of the interplay of the clinical and translational processes inherent to offsite clinical trials,” including workflow, community engagement, information platforms and digital health technologies. The RFI also invited public input on ways to improve the inclusion of diverse participants in DCTs or “hybrid trials.”

    In its letter, the AAMC expressed support for NCATS’ interest in accelerating the implementation of clinical trials and emphasized the need for robust intergovernmental collaboration, multisector alignment, and the active inclusion of state and local community voices. The association also made several key recommendations, which included the following: 

    Create opportunities for increased intergovernment coordination, especially given the current interest to improve the research infrastructure by the White House Office of Science Technology and Policy [refer to Washington Highlights, Feb. 3] and the Food and Drug Administration’s recent draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.

    The AAMC and the Center for Health Justice will continue to follow activities related to the NCATS RFI, along with other federal efforts to improve the clinical research infrastructure and accelerate research.