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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
  • 42 Health sciences
 

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
  • 42 Health sciences