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Clinical trials. How should they be designed?

Publication ,  Journal Article
Onken, JE; Brazer, SR
Published in: Gastrointest Endosc Clin N Am
April 1994

The fundamental principles of clinical trial design include (1) a priori formulation of a specific research question, (2) precise description of the population to be studied, (3) limitation of the effects of chance by predetermining the study hypothesis and using methods that account for multiple statistical testing, (4) calculation of the sample size necessary to answer the research question, and (5) limitation of the potential bias whenever possible through blinding and random allocation of subjects to treatment and control groups (Table 2). Although the randomized controlled trial is regarded as the gold standard for determination of efficacy of therapy, cost and sample size are frequently rate-limiting. Other techniques have been developed to supplement clinical trials and include meta-analysis, data base (observational) research, and decision analysis. In the current climate of concern over staggering health care costs and variable practice patterns, research emphases are shifting from cost containment to maximizing value of health-related services and assessing patient outcomes.

Duke Scholars

Published In

Gastrointest Endosc Clin N Am

ISSN

1052-5157

Publication Date

April 1994

Volume

4

Issue

2

Start / End Page

423 / 434

Location

United States

Related Subject Headings

  • Research Design
  • Humans
  • Gastroenterology & Hepatology
  • Clinical Trials as Topic
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Onken, J. E., & Brazer, S. R. (1994). Clinical trials. How should they be designed? Gastrointest Endosc Clin N Am, 4(2), 423–434.
Onken, J. E., and S. R. Brazer. “Clinical trials. How should they be designed?Gastrointest Endosc Clin N Am 4, no. 2 (April 1994): 423–34.
Onken JE, Brazer SR. Clinical trials. How should they be designed? Gastrointest Endosc Clin N Am. 1994 Apr;4(2):423–34.
Onken, J. E., and S. R. Brazer. “Clinical trials. How should they be designed?Gastrointest Endosc Clin N Am, vol. 4, no. 2, Apr. 1994, pp. 423–34.
Onken JE, Brazer SR. Clinical trials. How should they be designed? Gastrointest Endosc Clin N Am. 1994 Apr;4(2):423–434.
Journal cover image

Published In

Gastrointest Endosc Clin N Am

ISSN

1052-5157

Publication Date

April 1994

Volume

4

Issue

2

Start / End Page

423 / 434

Location

United States

Related Subject Headings

  • Research Design
  • Humans
  • Gastroenterology & Hepatology
  • Clinical Trials as Topic