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Statistical/practical issues in clinical trials

Publication ,  Journal Article
Pong, A; Chow, SC
Published in: Therapeutic Innovation & Regulatory Science
January 1, 1997

For approval of a drug product, the United States Food and Drug Administration (FDA) requires that substantial evidence of the effectiveness and safety of the drug product be provided through the conduct of two adequate, well-controlled clinical trials. To assist the sponsors in preparation of final clinical reports for regulatory submission and review, the FDA and other regulatory agencies and conferences such as the International Conference on Harmonization (ICH) have developed guidelines for the format and content of a clinical report. The FDA and ICH guidelines require that the following statistical issues be addressed in the final clinical report: 1. Baseline comparability, 2. Adjustments for covariates, 3. Dropouts or missing values, 4. Interim analyses and data monitoring, 5. Multicenter studies, 6. Multiplicity, 7. Intention-to-treat subset versus efficacy subset, 8. Active control trials, and 9. Subgroup analyses. This paper provides an overview of these statistical issues. In addition, statistical justification for these issues is also addressed. © 1997, Drug Information Association. All rights reserved.

Duke Scholars

Published In

Therapeutic Innovation & Regulatory Science

DOI

ISSN

2168-4790

Publication Date

January 1, 1997

Volume

31

Issue

4

Start / End Page

1167 / 1174

Related Subject Headings

  • Statistics & Probability
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Chicago
ICMJE
MLA
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Pong, A., & Chow, S. C. (1997). Statistical/practical issues in clinical trials. Therapeutic Innovation & Regulatory Science, 31(4), 1167–1174. https://doi.org/10.1177/009286159703100415
Pong, A., and S. C. Chow. “Statistical/practical issues in clinical trials.” Therapeutic Innovation & Regulatory Science 31, no. 4 (January 1, 1997): 1167–74. https://doi.org/10.1177/009286159703100415.
Pong A, Chow SC. Statistical/practical issues in clinical trials. Therapeutic Innovation & Regulatory Science. 1997 Jan 1;31(4):1167–74.
Pong, A., and S. C. Chow. “Statistical/practical issues in clinical trials.” Therapeutic Innovation & Regulatory Science, vol. 31, no. 4, Jan. 1997, pp. 1167–74. Scopus, doi:10.1177/009286159703100415.
Pong A, Chow SC. Statistical/practical issues in clinical trials. Therapeutic Innovation & Regulatory Science. 1997 Jan 1;31(4):1167–1174.
Journal cover image

Published In

Therapeutic Innovation & Regulatory Science

DOI

ISSN

2168-4790

Publication Date

January 1, 1997

Volume

31

Issue

4

Start / End Page

1167 / 1174

Related Subject Headings

  • Statistics & Probability
  • 1117 Public Health and Health Services
  • 0104 Statistics