A primer on clinical trial design

Urol Oncol. 2015 Mar;33(3):116-21. doi: 10.1016/j.urolonc.2014.12.014. Epub 2015 Jan 23.

Abstract

A well-designed and executed clinical trial is the gold standard of evidence-based medicine. It is important for readers to understand the rationale for the study design, identify common pitfalls, and scrutinize limitations. Herein, we present a brief overview of types of designs used for clinical trials and discuss the use of appropriate end points, the selection of study participants, randomization, sample size calculation, blinding, and analysis of data. Finally, we emphasize the importance of accurate and transparent reporting. Our goal is to provide a primer for practicing urologists to enhance their understanding of the clinical trial literature.

Keywords: Clinical trial; Clinical trial design; Randomized control study; Study design; Urology.

Publication types

  • Review

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Clinical Trials as Topic*
  • Healthy Volunteers
  • Humans
  • Medical Oncology / methods
  • Patient Selection
  • Random Allocation
  • Research Design*
  • Sample Size
  • Treatment Outcome
  • Urologic Neoplasms / therapy
  • Urology / methods

Substances

  • Antineoplastic Agents