Contents

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Clinical trial design 

Clinical trial design
Chapter:
Clinical trial design
DOI:
10.1093/med/9780199608478.003.0014
Page of

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date: 23 October 2020

This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is identified Elimination of bias is critical to the study design and methods of eliminating bias are discussed, defining the population, randomisation and blinding. A summary of the elements to be considered when designing a study are presented including the types of control, placebo or active, and their uses, Non comparative and comparative designs are presented. In the comparative design both within and between patient designs are discussed including crossover, parallel, sequential, factorial and left right comparisons. Patient outcomes measures as well as efficacy measurement are required for new treatments. There is a brief review of pharmaeconomic study designs. Other types of study design, dose escalation and dose response studies are also discussed. As well as reducing bias in studies another critical element is the recording of the primary assessment methods. The choice of methods will affect other aspects of the study such as the statistical considerations. The methodology must be standardised and validated.

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