Bridging clinical investigators and statisticians: Writing the statistical methodology for a research proposal

Beverley Adams-Huet, Chul Ahn

Research output: Contribution to journalReview article

8 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)818-824
Number of pages7
JournalJournal of Investigative Medicine
Issue number8
StatePublished - Dec 2009



  • Biostatistics
  • Clinical research
  • Protocol
  • Research proposal
  • Statistical methods
  • Statistician
  • Study design

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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