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Inference for clinical trials with some protocol amendments.

Publication ,  Journal Article
Chow, S-C; Shao, J
Published in: J Biopharm Stat
2005

The use of adaptive methods in clinical development has become very popular in recent years due to its flexibility in modifying trial procedures and/or statistical procedures of on-going clinical trials. Modifications to trial procedures are usually documented by protocol amendments. However, the actual patient population after protocol amendments could deviate from the originally targeted patient population. In addition, protocol amendments made based on accrued data of the on-going trial may distort the sampling distribution of the statistic designed for the case of no protocol change. In this article, we model the population deviations due to protocol amendments using some covariates and study how to develop a valid statistical inference procedure. An example concerning an asthma trial is presented for illustration.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2005

Volume

15

Issue

4

Start / End Page

659 / 666

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Population
  • Models, Statistical
  • Humans
  • Forced Expiratory Volume
  • Clinical Trials as Topic
  • Asthma
  • Anti-Asthmatic Agents
  • Algorithms
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chow, S.-C., & Shao, J. (2005). Inference for clinical trials with some protocol amendments. J Biopharm Stat, 15(4), 659–666. https://doi.org/10.1081/BIP-200062286
Chow, Shein-Chung, and Jun Shao. “Inference for clinical trials with some protocol amendments.J Biopharm Stat 15, no. 4 (2005): 659–66. https://doi.org/10.1081/BIP-200062286.
Chow S-C, Shao J. Inference for clinical trials with some protocol amendments. J Biopharm Stat. 2005;15(4):659–66.
Chow, Shein-Chung, and Jun Shao. “Inference for clinical trials with some protocol amendments.J Biopharm Stat, vol. 15, no. 4, 2005, pp. 659–66. Pubmed, doi:10.1081/BIP-200062286.
Chow S-C, Shao J. Inference for clinical trials with some protocol amendments. J Biopharm Stat. 2005;15(4):659–666.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

2005

Volume

15

Issue

4

Start / End Page

659 / 666

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Population
  • Models, Statistical
  • Humans
  • Forced Expiratory Volume
  • Clinical Trials as Topic
  • Asthma
  • Anti-Asthmatic Agents
  • Algorithms