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. 2021:2249:193-211.
doi: 10.1007/978-1-0716-1138-8_11.

Randomized Controlled Trials 1: Design

Bryan M Curtis  1 , Brendan J Barrett  2 , Patrick S Parfrey  2
Affiliations

Randomized Controlled Trials 1: Design

Bryan M Curtis et al. Methods Mol Biol. 2021.

Abstract

Today's clinical practice relies on the application of well-designed clinical research, the gold standard test of an intervention being the randomized controlled trial. Principles of the randomized control trial include emphasis on the principal research question, randomization, blinding; definitions of outcome measures, of inclusion and exclusion criteria, and of co-morbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity such as drop-out, drop-in, and bias. The application of pre-trial planning is stressed to ensure the proper application of epidemiological principles resulting in clinical studies that are feasible and generalizable. In addition, funding strategies and trial team composition are discussed.

Keywords: Clinical trial; blinding; randomization; sample size estimate.

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