Reflections on sharing clinical trial data : challenges and a way forward : proceedings of a workshop /
On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sh...
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| Format: | Conference Proceeding eBook |
| Language: | English |
| Published: |
Washington, DC :
The National Academies Press,
[2020]
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| Online Access: | CONNECT CONNECT |
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| 100 | 1 | |a Wizemann, Theresa M., |e raporteur. | |
| 245 | 1 | 0 | |a Reflections on sharing clinical trial data : |b challenges and a way forward : proceedings of a workshop / |c Theresa Wizemann, Eeshan Khandekar, Jennifer Hinners, and Carolyn Shore, rappourters ; Forum on Drug Discovery, Development, and Translation, Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, Roundtable on Genomics and Precision Health, Board on Health Sciences Policy, Board on Health Care Services, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine. |
| 264 | 1 | |a Washington, DC : |b The National Academies Press, |c [2020] | |
| 300 | |a 1 online resource (1 PDF file (xxvi, 135 pages)) : |b illustrations | ||
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| 504 | |a Includes bibliographical references. | ||
| 520 | 3 | |a On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop. | |
| 536 | |a This activity was supported by contracts between the National Academy of Sciences and AbbVie Inc.; Amgen Inc. (Contract No. GHCCOPS-CSARF-175837); Association of American Medical Colleges; AstraZeneca; Burroughs Wellcome Fund (Contract No. 1020264); Critical Path Institute; Eli Lilly and Company (Contract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; GlaxoSmithKline (Contract No. OTH-PPL-30507 and Contract No. OTH-PPL-32245); Johnson & Johnson; Merck & Co., Inc. (Contract No. MRLCPO-18-2641 and Contract No. MRLCPO-19-106723); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Extramural Research, Office of Science Policy; New England Journal of Medicine; Takeda Pharmaceuticals (Contract No. 53108); U.S. Food and Drug Administration (Grant No. 5R13FD005496-04 and Grant No. 5R13FD005496-05); and Wellcome Trust. 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. | ||
| 588 | |a Description based on online resource; title from PDF title page (viewed Dec. 17, 2020). | ||
| 505 | 0 | |a Intro -- FrontMatter -- Reviewers -- Acknowledgments -- Contents -- Boxes and Figures -- Acronyms and Abbreviations -- 1 Introduction -- 2 Perspectives on Current Data-Sharing Policies in Practice -- 3 Data-Sharing Platforms -- 4 Striking a Balance Between Benefit/Value and Risk/Cost -- 5 Data Interoperability and Platform Usability -- 6 Infrastructure Sustainability -- 7 Challenges and Disincentives for Sharing and Reuse of Data -- 8 Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges -- 9 Looking Forward: Incentivizing Data Sharing and Reuse | |
| 505 | 8 | |a Appendix A: References -- Appendix B: Workshop Agenda | |
| 650 | 0 | |a Clinical trials |x Data processing. | |
| 650 | 0 | |a Drugs |x Testing. | |
| 650 | 0 | |a Medicine |x Data processing. | |
| 650 | 0 | |a Medical informatics. | |
| 650 | 7 | |a Clinical trials |x Data processing. |2 fast |0 (OCoLC)fst00864430 | |
| 650 | 7 | |a Drugs |x Testing. |2 fast |0 (OCoLC)fst00898940 | |
| 650 | 7 | |a Medical informatics. |2 fast |0 (OCoLC)fst01014175 | |
| 650 | 7 | |a Medicine |x Data processing. |2 fast |0 (OCoLC)fst01014924 | |
| 700 | 1 | |a Khandekar, Eeshan, |e raporteur. | |
| 700 | 1 | |a Hinners, Jennifer, |e raporteur. | |
| 700 | 1 | |a Shore, Carolyn, |e raporteur. | |
| 710 | 2 | |a National Academies of Sciences, Engineering, and Medicine (U.S.). |b Forum on Drug Discovery, Development, and Translation, |e issuing body. | |
| 710 | 2 | |a National Academies of Sciences, Engineering, and Medicine (U.S.). |b Forum on Neuroscience and Nervous System Disorders, |e issuing body. | |
| 710 | 2 | |a National Cancer Policy Forum (U.S.), |e issuing body. | |
| 710 | 2 | |a National Academies of Sciences, Engineering, and Medicine (U.S.). |b Roundtable on Genomics and Precision Health, |e issuing body. | |
| 711 | 2 | |a Sharing Clinical Trial Data: Challenges and a Way Forward (Workshop) |d (2019 : |c Washington, DC) | |
| 776 | 0 | 8 | |i Print version: |a National Academies of Sciences, Engineering, and Medicine |t Reflections on Sharing Clinical Trial Data : Challenges and a Way Forward: Proceedings of a Workshop |d Washington, D.C. : National Academies Press,c2020 |z 9780309679152 |
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