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Statistical consideration of adaptive methods in clinical development.

Publication ,  Journal Article
Chow, S-C; Chang, M; Pong, A
Published in: J Biopharm Stat
2005

In recent years, the use of adaptive methods in clinical development based on accrued data has become very popular due to its flexibility in modifying trial procedures and/or statistical procedures of on-going clinical trials. However, it is a concern that the actual patient population after the modifications could deviate from the originally targeted patient population. Major modifications of trial procedures and/or statistical procedures of on-going trials may result in a totally different trial, which is unable to address the scientific/medical questions that the trial intends to answer.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2005

Volume

15

Issue

4

Start / End Page

575 / 591

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Research Design
  • Population
  • Dose-Response Relationship, Drug
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • Algorithms
  • 4905 Statistics
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chow, S.-C., Chang, M., & Pong, A. (2005). Statistical consideration of adaptive methods in clinical development. J Biopharm Stat, 15(4), 575–591. https://doi.org/10.1081/BIP-200062277
Chow, Shein-Chung, Mark Chang, and Annpey Pong. “Statistical consideration of adaptive methods in clinical development.J Biopharm Stat 15, no. 4 (2005): 575–91. https://doi.org/10.1081/BIP-200062277.
Chow S-C, Chang M, Pong A. Statistical consideration of adaptive methods in clinical development. J Biopharm Stat. 2005;15(4):575–91.
Chow, Shein-Chung, et al. “Statistical consideration of adaptive methods in clinical development.J Biopharm Stat, vol. 15, no. 4, 2005, pp. 575–91. Pubmed, doi:10.1081/BIP-200062277.
Chow S-C, Chang M, Pong A. Statistical consideration of adaptive methods in clinical development. J Biopharm Stat. 2005;15(4):575–591.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2005

Volume

15

Issue

4

Start / End Page

575 / 591

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Research Design
  • Population
  • Dose-Response Relationship, Drug
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • Algorithms
  • 4905 Statistics