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Guidelines for the Content of Statistical Analysis Plans in Clinical Trials
Carrol Gamble1, Ashma Krishan2, Deborah Stocken3,4
1Biostatistics Department, University of Liverpool, Liverpool, England.
JAMA
|December 21, 2017
Summary
New guidance addresses the content of statistical analysis plans (SAPs) for clinical trials, enhancing transparency and reproducibility. This framework ensures consistent reporting for better trial outcomes.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Regulatory Science
Background:
- Existing guidance on statistical principles for clinical trials lacks detail on the content of statistical analysis plans (SAPs).
- This absence hinders transparency and reproducibility in clinical trial reporting.
- A need exists for standardized recommendations for SAP content.
Framework:
- Developed recommendations for a minimum set of essential items for clinical trial SAPs.
- Input was gathered from diverse stakeholders including statisticians, guideline authors, journal editors, regulators, and funders.
- Utilized a multi-stage approach involving surveys and a Delphi method to achieve consensus.
Implementation:
- Conducted a survey of UK Clinical Research Collaboration-registered trial units (n=46) to assess current practices.
- A Delphi survey involving 73 participants reached consensus on 42% of 110 items.
- A consensus meeting of 12 experts refined the recommendations, resulting in 55 core items after review and piloting in 5 trials.
Implications:
- Provides a clear framework for the minimum content of SAPs in clinical trials.
- Aims to improve the quality, transparency, and reproducibility of clinical trial reporting.
- Highlights the critical role of SAPs, alongside trial registration and protocols, in ensuring robust scientific communication.
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