Methodology of clinical drug trials /

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Bibliographic Details
Author / Creator:Spriet, Alain
Uniform title:Méthodologie des essais cliniques des médicaments. English
Edition:2nd, rev. ed.
Imprint:Basel ; New York : Karger, c1994.
Description:viii, 269 p. : ill. ; 25 cm.
Language:English
Subject:Drugs -- Testing -- Methodology.
Clinical Trials -- methods
Drug Evaluation -- methods
Drugs -- Testing -- Methodology.
Format: Print Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/1617902
Hidden Bibliographic Details
Other authors / contributors:Dupin-Spriet, Thérèse
Simon, Pierre, M.D.
ISBN:3805558562
Notes:Includes bibliographical references and index.
committed to retain 20170930 20421213 HathiTrust
Table of Contents:
  • 1. Introduction
  • 2. Principles of the controlled trial
  • 3. Selection of subjects
  • 4. Efficacy assessment
  • 5. Randomization
  • 6. Single-blind and double-blind trials
  • 7. Choice of the comparator: placebo or active drug?
  • 8. Dosage and therapeutic schema
  • 9. Experimental designs
  • 10. Subjects lost to follow-up
  • 11. Patient compliance and discontinuation of treatment
  • 12. Case report forms
  • 13. Multicenter trials
  • 14. Imperfect data analysis
  • 15. Confirmatory analysis of the principal evaluation criterion
  • 16. Interim analyses
  • 17. Exploratory analyses
  • 18. Pragmatic trials. Decision methods
  • 19. Safety data
  • 20. Sample size
  • 21. Prudence and protection of participants
  • 22. Preparing a protocol
  • 23. Index.