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The ABC of pharmaceutical trial design: some basic principles
Author(s) -
Julious Steven,
Zariffa Névine
Publication year - 2002
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.6
Subject(s) - blinding , clinical trial , context (archaeology) , medical physics , pharmaceutical industry , consolidated standards of reporting trials , clinical study design , reliability (semiconductor) , clinical endpoint , medicine , randomized controlled trial , management science , computer science , risk analysis (engineering) , engineering , pharmacology , surgery , pathology , paleontology , power (physics) , quantum mechanics , biology , physics
This is a teaching paper intended as a quick introduction to some of the key concepts in the design of pharmaceutical trials for those new to the industry. Since the first ‘modern’ randomized clinical trial was reported in 1948 by the Medical Research Council, clinical trials have become a central component in the assessment of new therapies. The primary objective of any clinical trial is to obtain an unbiased and reliable assessment of a given regimen response independent of any known or unknown prognostic factors. The essential principals of trial design can be thought of as the ABC of allocation at random, blinding and controlled. In addition, the three Rs of endpoint selection – representative, reliability and reproducibility – are relevant in this context. This paper briefly describes the basic concepts for clinical trials and highlights possible points to consider. It draws heavily on the principles highlighted in the International Conference on Harmonisation guidelines as well as recommendations in the CONSORT statement. Copyright © 2002 John Wiley & Sons, Ltd.