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Bridging Clinical Investigators and Statisticians
  1. Beverley Adams-Huet, MS,
  2. Chul Ahn, PhD
  1. From the Department of Clinical Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, TX.
  1. Received June 27, 2009, and in revised form September 16, 2009.
  2. Accepted for publication September 16, 2009.
  3. Reprints: Beverley Adams-Huet, MS, Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd, Dallas, TX 75390-9066. E-mail: Beverley.huet{at}utsouthwestern.edu.
  4. This study was supported by the National Institutes of Health-Clinical and Translational Science Award grant UL1 RR024982.

Writing the Statistical Methodology for a Research Proposal

Abstract

Clinical investigators often find the thought of writing the statistical analysis plan daunting. Early collaboration between the clinical investigator and statistician can improve the study design and validity of the results by developing the statistical methodology that specifically addresses the research hypothesis. With the clinical investigator, a statistician often writes the statistical methods section that includes sample size and power analyses, randomization and blinding procedures, interim analysis, and data monitoring plans, in addition to the statistical analysis plan. To make this process less mysterious, we describe how the statistical methods section is developed in collaboration with a statistician.

Key Words
  • statistical methods
  • statistician
  • clinical research
  • research proposal
  • protocol
  • study design
  • biostatistics
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