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Adaptive clinical trial design.

Publication ,  Journal Article
Chow, S-C
Published in: Annu Rev Med
2014

In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its flexibility and efficiency in pharmaceutical/clinical development. In practice, adaptive design may provide the investigators a second chance to modify or redesign the trial while the study is still ongoing. However, it is a concern that a shift in target patient population may occur after significant adaptations are made. In addition, the overall type I error rate may not be preserved. Moreover, the results may not be reliable and hence are difficult to interpret. As indicated by the US Food and Drug Administration draft guidance on adaptive design clinical trials, the adaptive design has to be a prospectively planned opportunity and should be based on information collected within the study, with or without formal statistical hypothesis testing. This article reviews the relative advantages, limitations, and feasibility of commonly considered adaptive designs in clinical trials. Statistical concerns when implementing adaptive designs are also discussed.

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Published In

Annu Rev Med

DOI

EISSN

1545-326X

Publication Date

2014

Volume

65

Start / End Page

405 / 415

Location

United States

Related Subject Headings

  • Statistics as Topic
  • Research Design
  • Humans
  • General & Internal Medicine
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase I as Topic
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chow, S.-C. (2014). Adaptive clinical trial design. Annu Rev Med, 65, 405–415. https://doi.org/10.1146/annurev-med-092012-112310
Chow, Shein-Chung. “Adaptive clinical trial design.Annu Rev Med 65 (2014): 405–15. https://doi.org/10.1146/annurev-med-092012-112310.
Chow S-C. Adaptive clinical trial design. Annu Rev Med. 2014;65:405–15.
Chow, Shein-Chung. “Adaptive clinical trial design.Annu Rev Med, vol. 65, 2014, pp. 405–15. Pubmed, doi:10.1146/annurev-med-092012-112310.
Chow S-C. Adaptive clinical trial design. Annu Rev Med. 2014;65:405–415.

Published In

Annu Rev Med

DOI

EISSN

1545-326X

Publication Date

2014

Volume

65

Start / End Page

405 / 415

Location

United States

Related Subject Headings

  • Statistics as Topic
  • Research Design
  • Humans
  • General & Internal Medicine
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase I as Topic
  • 3202 Clinical sciences
  • 1103 Clinical Sciences