期刊
BMJ-BRITISH MEDICAL JOURNAL
卷 376, 期 -, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmj-2021-068177
关键词
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资金
- National Institute for Health Research (NIHR) Clinical Trials Unit Support Funding scheme
- Cancer Research UK [C22436/A25354, C22436/A28028]
- Birmingham Biomedical Research Centre (NIHR)
- Advanced Therapy Treatment Centre (Innovate UK)
- UK Clinical Research Collaboration Registered Clinical Trials Unit Network
This paper presents guidelines for the content of statistical analysis plans for early phase clinical trials. These guidelines specify the minimum reporting analysis requirements by providing extensions and modifications to existing guidance based on a review by various stakeholders.
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.
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