Trial Design: Overview of Study Designs

  • Puneet Singh
  • Yu Shen
  • Kelly K. HuntEmail author
Part of the Success in Academic Surgery book series (SIAS)


Clinical trials are fundamentally the investigation of human subjects under experimental conditions. For these trials to be successful, they must be well planned in the design phase to evaluate the prespecified outcomes. Thus, it is imperative for the investigators to understand clinical trial design which follows a typical progression from preclinical studies in animals to phase I–IV trials as described in this chapter (Fig. 4.1).


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© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Division of Surgery, Department of Breast Surgical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Department of BiostatisticsThe University of Texas MD Anderson Cancer CenterHoustonUSA

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