统计分析计划(SAP)报告指南的解读及其对中医药临床研究的启示
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摘要
统计分析计划(SAP)是增加临床研究流程透明度、数据可信度、操作规范性、结果有效性和结论可接受度的途径之一,用于全面和翔实地记录临床研究方案中所描述的分析方法的原则,包括对主要变量、次要变量和其他数据的统计分析过程。SAP报告内容的指南共包括管理信息(11个条目/亚条目)、研究简介(2个条目)、研究方法 (9个条目/亚条目)、统计学原则(8个条目/亚条目)、试验人群(8个条目/亚条目)和分析(17个条目/亚条目) 6部分内容。SAP的发表可提升临床研究的效率,减少科研基金不必要的浪费;为临床试验阶段性成果的交流提供平台;提升试验从设计到报告的透明性;提高临床试验的可重复性。
Statistical analysis plan( SAP) is one of the methods to strengthen study transparency,data credibility,operating standardization,results validity and conclusion acceptability for comprehensively and informatively recording the principles of analysis described in clinical research protocols,including the statistical analysis of major variables,minor variables,and other data. The guidelines for SAP report content include management information( 11 items/sub-items),research profiles( 2 items),research methods( 9 items/sub-items),statistical principles( 8 items/sub-items),trials subjects( 8 items/sub-items) and analysis( 17 items/sub-items). The publication of SAP can improve the efficiency of clinical research,reduce unnecessary waste of research funds,provide a platform for the exchange of clinical trials,improve the transparency of design from report to report,and improve the repeatability of clinical trials.
Statistical analysis plan( SAP) is one of the methods to strengthen study transparency,data credibility,operating standardization,results validity and conclusion acceptability for comprehensively and informatively recording the principles of analysis described in clinical research protocols,including the statistical analysis of major variables,minor variables,and other data. The guidelines for SAP report content include management information( 11 items/sub-items),research profiles( 2 items),research methods( 9 items/sub-items),statistical principles( 8 items/sub-items),trials subjects( 8 items/sub-items) and analysis( 17 items/sub-items). The publication of SAP can improve the efficiency of clinical research,reduce unnecessary waste of research funds,provide a platform for the exchange of clinical trials,improve the transparency of design from report to report,and improve the repeatability of clinical trials.
引文
[1]GAMBLE C,KRISHAN A,STOCKEN D,et al. Guidelines for the content of statistical analysis plans in clinical trials[J]. JAMA,2017,318(23):2337-2343.
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[3]BEGG C,CHO M,EASTWOOD S,et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA,1996,276(8):637-639.
[4]SCHULZ KF,ALTMAN DG,MOHER D,et al. CONSORT 2010 Statement:updated guidelines for reporting parallel group randomised trials[J]. Ann Int Med,2010,152(11):726-732.
[5]CHAN AW,HRBJARTSSON A,HAAHR MT,et al.Empirical evidence for selective reporting of outcomes in randomized trials:comparison of protocols to published articles[J]. JAMA,2004,291(20):2457-2465.
[6]FINFER S,BELLOMO R. Why publish statistical analysis plans?[J]. Crit Care Resusc,2009,11(1):5-6.
[7]FINFER S,HERITIER S. The NICE-SUGAR(Normoglycaemia in intensive care evaluation and survival using glucose algorithm regulation)study:statistical analysis plan[J]. Crit Care Resusc,2009,11(1):46-57,58-66.
[8]LU L,XUAN M,YAN Y,et al. A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris[J]. Trials,2016,17:482. doi. 10. 1186/S13063-016-1610-8.
[9]ZHANG Y,SUN J,ZHANG YJ,et al. The effect of berberine on insulin resistance in women with polycystic ovary syndrome:detailed statistical analysis plan(SAP)for a multicenter randomized controlled trial[J]. Trials,2016,17:512. doi:10. 1186/S13063-016-1633-5.
[10]JIANG K,CAO X. Design and implementation of an audit trail in compliance with US regulations[J]. Clin Trials,2011,8(5):624-633.
[11]FDA. Guidance for Industry Part 11,Electronic Records; Electronic Signatures-Scope and Application[EB/OL].(2003-01-01)[2018-05-25]. https://www.fda. gov/downloads/regulatoryinformation/guidances/ucm125125. pdf.
[12]LAO L,HUANG Y,FENG C,et al. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology:application to a randomized controlled acupuncture trial[J]. Stat Med,2012,31(7):619-627.
[13]国家食品药品监督管理总局.中药新药临床研究一般原则[EB/OL].(2015-11-03)[2018-05-25].http://samr. cfda. gov. cn/WS01/CL1616/134582. html.
[14]STEPHEN SENN. Statistical issues in drug development[M]. Chichester England:John Wiley&Sons,2002:58.
[2]The International Council for Hamonization(ICH):E9 statistical principles for clinical trials[M/OL].(1998-01-01)[2018-05-25]. http://www. ich. org/products/guidelines/efficacy/article/efficacy-guidelines. html.
[3]BEGG C,CHO M,EASTWOOD S,et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA,1996,276(8):637-639.
[4]SCHULZ KF,ALTMAN DG,MOHER D,et al. CONSORT 2010 Statement:updated guidelines for reporting parallel group randomised trials[J]. Ann Int Med,2010,152(11):726-732.
[5]CHAN AW,HRBJARTSSON A,HAAHR MT,et al.Empirical evidence for selective reporting of outcomes in randomized trials:comparison of protocols to published articles[J]. JAMA,2004,291(20):2457-2465.
[6]FINFER S,BELLOMO R. Why publish statistical analysis plans?[J]. Crit Care Resusc,2009,11(1):5-6.
[7]FINFER S,HERITIER S. The NICE-SUGAR(Normoglycaemia in intensive care evaluation and survival using glucose algorithm regulation)study:statistical analysis plan[J]. Crit Care Resusc,2009,11(1):46-57,58-66.
[8]LU L,XUAN M,YAN Y,et al. A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris[J]. Trials,2016,17:482. doi. 10. 1186/S13063-016-1610-8.
[9]ZHANG Y,SUN J,ZHANG YJ,et al. The effect of berberine on insulin resistance in women with polycystic ovary syndrome:detailed statistical analysis plan(SAP)for a multicenter randomized controlled trial[J]. Trials,2016,17:512. doi:10. 1186/S13063-016-1633-5.
[10]JIANG K,CAO X. Design and implementation of an audit trail in compliance with US regulations[J]. Clin Trials,2011,8(5):624-633.
[11]FDA. Guidance for Industry Part 11,Electronic Records; Electronic Signatures-Scope and Application[EB/OL].(2003-01-01)[2018-05-25]. https://www.fda. gov/downloads/regulatoryinformation/guidances/ucm125125. pdf.
[12]LAO L,HUANG Y,FENG C,et al. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology:application to a randomized controlled acupuncture trial[J]. Stat Med,2012,31(7):619-627.
[13]国家食品药品监督管理总局.中药新药临床研究一般原则[EB/OL].(2015-11-03)[2018-05-25].http://samr. cfda. gov. cn/WS01/CL1616/134582. html.
[14]STEPHEN SENN. Statistical issues in drug development[M]. Chichester England:John Wiley&Sons,2002:58.