Forum on Drug Discovery, Development, and Translation 10 Year Review: 2011-2020 (2021) / Chapter Skim
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Reflecting Back: Forum Activities in 2011-2020
Reflecting Back: Forum Activities in 2011-2020
Pages 8-23
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clinical been made to improve public trials enterprise and its competitiveness on the global stage, the forum convened participation throughout a public workshop for stakeholders to lay out a vision for a transformed clinical trials enterprise in the United States by 2020. At the time, there was growing recognition the drug R&D lifecycle.
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The 2012 FDA Safety and Innovation Act2 and corresponding fifth authorization of the Prescription Drug User Fee Act (PDUFA V) included provisions to enhance the role of the patient voice in the drug development process.
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Participants discuss actions stakeholders could take to improve transparent reporting of biomedical research during a 2019 workshop on Enhancing Scientific Reproducibility Through Transparent Reporting.
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Building the Infrastructure and Workforce The clinical trials infrastructure requires substantial resources to recruit investigators, coordinate across research sites, implement quality control systems, enroll and retain trial participants, and seek regulatory approval. Responsible sharing of clinical trial data is in the public interest and helps maximize the benefits of research for future patients and society as a whole.
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Sharing Clinical Trial Data -- An Action Collaborative6 A related action collaborative jointly convened by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health was launched in 2016. Through meetings with interested parties, including nonprofit funders of research, patient advocacy organizations, and data sharing stakeholders, the action collaborative developed and refined a statement of data-sharing goals that could be incorporated into participating organizations' funding policies.
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" lays out questions to help stakeholders assess potential error or bias at each step of data generation from clinical presentation (including with a device) to inclusion in a database.11 5 The full text of Sharing Clinical Research Data: Workshop Summary (IOM, 2013)
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" lays out questions to help stakeholders determine whether blinding and treatment standardization may be necessary for the internal validity of a study or may distort meaningful differences between treatments in specific cases.12 • "When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments? " lays out questions to help stakeholders evaluate the potential impact of confounding or other 14 biases on their research findings.13
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Workshop participants discussed the inefficiencies of the existing clinical trial enterprise; the boundaries of what might be considered a virtual clinical trial; opportunities to expand access for patients; perspectives of using digital health technologies in clinical care and observational and interventional studies; impact of using digital health technologies on access and equity to clinical trials; policy landscape governing clinical trials; and possible opportunities for future action. 12 The article "When Are Treatment Blinding and Treatment Standardization Necessary in Real-World Clinical Trials?
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"A Dynamic regulatory decision-making Map for Learning, Communicating, Navigating, and Improving Therapeutic Development" was published in Nature Reviews Drug Discovery18 and processes. "Application of a Dynamic Map for Learning, Communicating, Navigating, and Improving Therapeutic Development" was simultaneously published in Clinical and Translational Science.19 The Role of Digital Health Technologies in Drug Development -- A Workshop (2020)
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18 The article "A Dynamic Map for Learning, Communicating, Navigating, and Improving Therapeutic Development" (2017) published in Nature Reviews Drug Discovery is available at https://www.nature.com/articles/nrd.2017.217.
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Workshop participants assessed the current landscape of genomic enabled drug discovery and development activities; examined enabling partnerships and better business models; and considered gaps and best practices in how data from populations could be collected with the goal of improving the drug discovery process. Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development -- A Workshop (2018)
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23 In collaboration with the Forum on Neuroscience and Nervous System Disorders, the National Cancer Policy Forum, and the Roundtable on Genomics and Precision Health, the forum convened a workshop on September 25–26, 2019, to examine the state of transparency in reporting biomedical research (e.g., disclosure of the availability and location of data, materials, analyses, and methodology) and to explore the possibility of improving the harmonization of guidelines across journals and funding agencies so that biomedical researchers propose and report data in a consistent manner.
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Forum members (from left to right) Ross McKinney, Jr., Anantha Shekhar, Bernard Munos, and Ann E
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Converting traditionally anecdotal patient input to rigorous, credible evidence could better align medical product development and regulation with patient perspectives on disease experience, burden, management, and treatment. The forum convened a workshop on May 9, 2018, focused on the science of patient input for pre-market medical product R&D (including pre-discovery, discovery, pre-clinical development, and clinical development)
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In that same year, the FDA Science Board,28 at the request of Congress, reported on the agency's need for an enhanced science base, The development and including infrastructure development, multisector collaboration, and an expanded application of regulatory workforce capable of addressing the rapidly evolving science of drug discovery and science .
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On September 20–21, 2011, the forum held a public workshop that considered the opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce. Workshop participants discussed the core components of a robust discipline of regulatory science; deliberated on the key competencies for a regulatory science workforce; and examined the needs and opportunities to promote training, career development, and collaborative approaches to sustain and nurture a workforce in innovative regulatory science.
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