A framework for the pre-specification of statistical analysis strategies in clinical trials (Pre-SPEC)

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Title: A framework for the pre-specification of statistical analysis strategies in clinical trials (Pre-SPEC)
Authors: Kahan, BC
Forbes, G
Cro, S
Item Type: Working Paper
Abstract: Bias can be introduced into clinical trials if statistical methods are chosen based on subjective assessment of the trial data. Pre-specification of the planned analysis approach is essential to help reduce such bias. However, many trials fail to adequately pre-specify their statistical analysis approach, thereby allowing analysts to choose the method which gives the most favourable result. We propose a five-point framework for the pre-specification of the statistical analysis strategy for a clinical trial's primary outcome (the Pre-SPEC framework); this framework is designed to ensure that methods cannot be chosen based on the trial data in order to give a more favourable result. The five points are: (1) Pre-specify before recruitment to the trial begins; (2) Specify a single primary analysis strategy; (3) Plan all aspects of the analysis; (4) Enough detail should be provided so that a third party could independently perform the analysis; and (5) Adaptive analysis strategies should use deterministic decision rules. This framework could be used as a template to help plan an analysis strategy, or to evaluate whether an existing strategy is at risk of bias due to inadequate pre-specification.
Issue Date: 9-Jul-2019
URI: http://hdl.handle.net/10044/1/72618
Publisher: arxiv
Copyright Statement: © 2019 The Authors.
Keywords: stat.ME
Notes: 18 pages, 3 tables, 0 figures
Publication Status: Published
Appears in Collections:Epidemiology, Public Health and Primary Care

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