Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
Publication
, Journal Article
Wallach, JD; Zhang, AD; Skydel, JJ; Bartlett, VL; Dhruva, SS; Shah, ND; Ross, JS
Published in: Jama Network Open
November 2021
Duke Scholars
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Published In
Jama Network Open
DOI
EISSN
2574-3805
ISSN
2574-3805
Publication Date
November 2021
Volume
4
Issue
11
Start / End Page
e2133667
Related Subject Headings
- United States Food and Drug Administration
- United States
- Product Surveillance, Postmarketing
- Pragmatic Clinical Trials as Topic
- Humans
- Feasibility Studies
- Drug Approval
- Data Science
- Cross-Sectional Studies
Citation
APA
Chicago
ICMJE
MLA
NLM
Wallach, J. D., Zhang, A. D., Skydel, J. J., Bartlett, V. L., Dhruva, S. S., Shah, N. D., & Ross, J. S. (2021). Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. Jama Network Open, 4(11), e2133667. https://doi.org/10.1001/jamanetworkopen.2021.33667
Wallach, Joshua D., Audrey D. Zhang, Joshua J. Skydel, Victoria L. Bartlett, Sanket S. Dhruva, Nilay D. Shah, and Joseph S. Ross. “Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.” Jama Network Open 4, no. 11 (November 2021): e2133667. https://doi.org/10.1001/jamanetworkopen.2021.33667.
Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, et al. Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. Jama Network Open. 2021 Nov;4(11):e2133667.
Wallach, Joshua D., et al. “Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.” Jama Network Open, vol. 4, no. 11, Nov. 2021, p. e2133667. Epmc, doi:10.1001/jamanetworkopen.2021.33667.
Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, Ross JS. Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. Jama Network Open. 2021 Nov;4(11):e2133667.
Published In
Jama Network Open
DOI
EISSN
2574-3805
ISSN
2574-3805
Publication Date
November 2021
Volume
4
Issue
11
Start / End Page
e2133667
Related Subject Headings
- United States Food and Drug Administration
- United States
- Product Surveillance, Postmarketing
- Pragmatic Clinical Trials as Topic
- Humans
- Feasibility Studies
- Drug Approval
- Data Science
- Cross-Sectional Studies