Methodology of clinical drug trials /

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.