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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop (2022)

Chapter: References

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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
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References

AstraZeneca. 2020. Clinical study protocol—amendment 2 AZD1222-D8110C00001. https://s3.amazonaws.com/ctr-med-7111/D8110C00001/52bec400-80f6-4c1b-8791-0483923d0867/c8070a4e-6a9d-46f9-8c32-cece903592b9/D8110C00001_CSP-v2.pdf (accessed August 3, 2021).

Baxter, R., N. Taylor, I. Kellar, and R. Lawton. 2016. What methods are used to apply positive deviance within healthcare organisations? A systematic review. BMJ Quality & Safety 25(3):190–201.

Bugin, K., and J. Woodcock. 2021. Trends in COVID-19 therapeutic clinical trials. Nature Review Drug Discovery 20:254–255.

CDC (Centers for Disease Control and Prevention). 2021. Risk for COVID-19 infection, hospitalization, and death by race/ethnicity. https://www.cdc.gov/coronavirus/2019-ncov/coviddata/investigations-discovery/hospitalization-death-by-race-ethnicity.html (accessed August 3, 2021).

Collins, R., L. Bowman, M. Landray, and R. Peto. 2020. The magic of randomization versus the myth of real-world evidence. New England Journal of Medicine 382(7):674–678.

COVID R&D Alliance. 2021. https://www.covidrdalliance.com (accessed August 3, 2021).

Emanuel, E. J., C. Zhang, and A. Diana. 2020. Where is America’s groundbreaking COVID-19 research? The U.S. could learn a lot from Britain. The New York Times, September 1, https://www.nytimes.com/2020/09/01/opinion/coronavirus-clinical-research.html (accessed July 1, 2021).

FDA (U.S. Food and Drug Administration). 2020a. Conduct of clinical trials of medical products during the COVID-19 public health emergency: Guidance for industry, investigators, and institutional review boards. https://www.fda.gov/media/136238/download (accessed August 3, 2021).

FDA. 2020b. Drug trials snapshots summary report 2015–2019. https://www.fda.gov/media/143592/download (accessed August 3, 2021).

IOM (Institute of Medicine). 2012. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press.

Page 80 Cite
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
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Janssen Vaccines and Prevention. 2020. VAC31518 (JNJ-78436735) clinical protocol VAC31518COV3001 amendment 1. https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol (accessed August 3, 2021).

Korn, E., B. Freidlin, M. Mooney, and J. S. Abrams. 2010. Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007. Journal of Clinical Oncology 28(35):5197–5201.

Moderna TX. 2020. Protocol mRNA-1273-P301, amendment 3. https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf (accessed August 3, 2021).

NASEM (National Academies of Sciences, Engineering, and Medicine). 2018. Advancing the science of patient input in medical product R&D: Towards a research agenda: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press.

NASEM. 2020. The role of digital health technologies in drug development: Proceedings of a workshop. Washington, DC: The National Academies Press.

NCHS (National Center for Health Statistics). 2021. Health, United States, 2019: Tables 14, 22, 26. https://www.cdc.gov/nchs/hus/contents2019.htm (accessed August 3, 2021).

Pfizer Inc. 2020. PF-07302048 (BNT162 RNA-based COVID-19 vaccines) protocol C4591001. https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf (accessed August 3, 2021).

Steinhubl, S. R., D. L. Wolff-Hughes, W. Nilsen, E. Iturriaga, and R. M. Califf. 2019. Digital clinical trials: Creating a vision for the future. npj Digital Medicine 2:126.

TransCelerate (TransCelerate Biopharma Inc.). 2020. COVID-19 data sharing via DataCelerate. https://www.transceleratebiopharmainc.com/covid-19 (accessed August 3, 2021).

Page 79 Cite
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
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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.

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