Guidelines for the content of statistical analysis plans in clinical trials

Gamble, CL ORCID: 0000-0002-3021-1955, Krishan, Ashma, Stocken, Deborah, Lewis, Steff, Juszczak, Edmund, Dore, Caroline, Williamson, Paula ORCID: 0000-0001-9802-6636, Altman, Douglas, Montgomery, Alan, Lim, Pilar
et al (show 5 more authors) (2017) Guidelines for the content of statistical analysis plans in clinical trials. JAMA: Journal of the American Medical Association, 318 (23). pp. 2337-2343.

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Importance: While guidance on statistical principles for clinical trials exists there is an absence of guidance covering the required content of statistical analysis plans to support transparency and reproducibility. Objective: To develop recommendations for a minimum set of items that should be addressed in statistical analysis plans for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators and funders. Design: Funders and regulators (N=39) of randomized trials were contacted and the literature was searched to identify existing guidance; a survey of current practice was conducted across the network of UK Clinical Research Collaboration registered trials units (N=46, 1 unit had 2 responders) and a Delphi survey (N=73 invited) was conducted to establish consensus on statistical analysis plans. The Delphi survey was sent to statisticians in trials unit who completed the survey of current practice (N=46), CONSORT and SPIRIT guideline authors (N=16), pharmaceutical industry statisticians (N=5), journal editors (N=7), and regulators (N=2) (3 participants were included in 2 groups each), culminating in a consensus meeting attended by experts (N=12) with representatives from each group. The guidance subsequently underwent critical review by statisticians from the surveyed trials units and members of the expert panel of the consensus meeting (N=51) , followed by piloting of the guidance document in the statistical analysis plans of 5 trials. Findings: No existing guidance was identified. The registered trials unit survey (46 responses) highlighted diversity in current practice and confirmed support for developing guidance. The Delphi survey (54 of 73, 74% participants completing both rounds) reached consensus on 42% (N=46) of 110 items. The expert panel (N=12) agreed that 63 items should be included in the guidance with an additional 17 items identified as important but may be referenced elsewhere. Following critical review and piloting some overlapping items were combined leaving 55 items. Conclusions and relevance: Recommendations are provided for a minimum set of items that should be addressed and included in statistical analysis plans for clinical trials.

Item Type: Article
Uncontrolled Keywords: Data Interpretation, Statistical, Delphi Technique, Clinical Trials as Topic, Statistics as Topic
Depositing User: Symplectic Admin
Date Deposited: 21 Dec 2017 15:52
Last Modified: 19 Jan 2023 06:46
DOI: 10.1001/jama.2017.18556
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