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The Design of Randomized Controlled Trials

  • Bryan M. CurtisEmail author
  • Brendan J. Barrett
  • Patrick S. Parfrey
Protocol
Part of the Methods in Molecular Biology™ book series (MIMB, volume 473)

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 controlled trial include emphasis on the principal research question, randomization, and blinding; definitions of outcome measures, inclusion and exclusion criteria, and comorbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity, such as dropout, drop-in, and bias. The application of pretrial 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

Key Words

Clinical trial randomization blinding sample size estimate 

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Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Bryan M. Curtis
    • 1
    Email author
  • Brendan J. Barrett
  • Patrick S. Parfrey
  1. 1.Health Sciences CentreNewfoundlandCanada

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