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Reproducibility probability in clinical trials.

Publication ,  Journal Article
Shao, J; Chow, S-C
Published in: Stat Med
June 30, 2002

For marketing approval of a new drug product, the United States Food and Drug Administration (FDA) requires that substantial evidence of the effectiveness of the drug product be provided through the conduct of at least two adequate and well-controlled clinical trials. The purpose of conducting the second clinical trial is to study whether the clinical result from the first trial is reproducible in the second trial with the same study protocol. Under certain circumstance, the FDA Modernization Act of 1997 includes a provision to allow data from one adequate and well-controlled clinical trial investigation and confirmatory evidence to establish effectiveness for risk/benefit assessment of drug and biological candidates for approval. In this paper, we introduce the concept of reproducibility probability for a given clinical trial, which is useful in providing important information for regulatory agencies in deciding whether a single clinical trial is sufficient and for pharmaceutical companies in adjusting the sample size in a future clinical trial. Three approaches, the estimated power approach, the method of confidence bounds and the Bayesian approach, are studied in evaluating reproducibility probabilities under several study designs commonly used in clinical trials.

Duke Scholars

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Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

June 30, 2002

Volume

21

Issue

12

Start / End Page

1727 / 1742

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Schizophrenia
  • Reproducibility of Results
  • Randomized Controlled Trials as Topic
  • Middle Aged
  • Humans
  • Drug Approval
  • Bayes Theorem
 

Citation

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Shao, J., & Chow, S.-C. (2002). Reproducibility probability in clinical trials. Stat Med, 21(12), 1727–1742. https://doi.org/10.1002/sim.1177
Shao, Jun, and Shein-Chung Chow. “Reproducibility probability in clinical trials.Stat Med 21, no. 12 (June 30, 2002): 1727–42. https://doi.org/10.1002/sim.1177.
Shao J, Chow S-C. Reproducibility probability in clinical trials. Stat Med. 2002 Jun 30;21(12):1727–42.
Shao, Jun, and Shein-Chung Chow. “Reproducibility probability in clinical trials.Stat Med, vol. 21, no. 12, June 2002, pp. 1727–42. Pubmed, doi:10.1002/sim.1177.
Shao J, Chow S-C. Reproducibility probability in clinical trials. Stat Med. 2002 Jun 30;21(12):1727–1742.
Journal cover image

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

June 30, 2002

Volume

21

Issue

12

Start / End Page

1727 / 1742

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Schizophrenia
  • Reproducibility of Results
  • Randomized Controlled Trials as Topic
  • Middle Aged
  • Humans
  • Drug Approval
  • Bayes Theorem