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Author Wizemann, Theresa M., rapporteur.

Title Envisioning a transformed clinical trials enterprise for 2030 : proceedings of a workshop / Theresa Wizemann, Amanda Wagner Gee, and Carolyn Shore, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine.

Publication Info. Washington, DC : National Academies Press, [2022]

Item Status

Description 1 online resource (1 PDF file (xviii, 120 pages)) : illustrations
Bibliography Includes bibliographical references.
Summary The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.
Funding This activity was supported by contracts between the National Academy of Sciences and Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Biomedical Advanced Research and Development Authority; Burroughs Wellcome Fund (Contract No. 1021334); Critical Path Institute; Eli Lilly and Company (Contract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable; Merck & Co., Inc. (Contract No. MRLCPO-21-138769); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; Sanofi (Contract No. 65873711); Takeda Pharmaceuticals; U.S. Food and Drug Administration (Grant No. 1R13FD007302-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject Drug testing -- Statistical methods.
Clinical trials -- Law and legislation -- United States.
United States
Clinical trials -- Law and legislation
United States https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq
Genre/Form Congress
proceedings (reports)
Conference papers and proceedings.
Added Author Gee, Amanda Wagner, rapporteur.
Shore, Carolyn, rapporteur.
National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, issuing body.
Envisioning a Transformed Clinical Trials Enterprise for 2030 (Workshop) (2021 : Online)
Other Form: Original 0309269288 9780309269285 (OCoLC)1286311525
ISBN 9780309269315 (electronic bk.)
0309269318 (electronic bk.)
9780309269285
0309269288
9780309269292 (electronic bk.)
0309269296 (electronic bk.)