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J Investig Med. 2009 Dec;57(8):818-24. doi: 10.2310/JIM.0b013e3181c2996c.

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

Author information

1
Department of Clinical Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-9066, USA. Beverley.huet@utsouthwestern.edu

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.

PMID:
19875966
PMCID:
PMC4415704
DOI:
10.2310/JIM.0b013e3181c2996c
[Indexed for MEDLINE]
Free PMC Article

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