What Have We Learned about Trial Design From NIMH-Funded Pragmatic Trials?
What Have We Learned about Trial Design From NIMH-Funded Pragmatic Trials?
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DOI：
10.1038/npp.2010.115
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发表时间：
2010-12-01
影响因子：
7.6
通讯作者：
Glick, Ira D.
中科院分区：
文献类型：
--
作者：
March, John;Kraemer, Helena C.;Glick, Ira D.
在美国神经精神药理学会(ACNP)2008年年会上，一场研讨会专门讨论了以下问题：从最近昂贵的长期、大规模的精神治疗试验中，我们对实用临床试验(PCT)的设计有什么了解？以便为未来试验的设计提供信息。总共产生了10项建议，强调(1)适当进行实用试验；(2)临床意义，而不仅仅是统计学意义；(3)要求临床医生进行治疗的人群样本；(4)患者的临床结果，而不是结果衡量；(5)在必要时而不是在其他情况下使用分层、控制或调整；(6)在多点研究中适当考虑地点差异；(7)鼓励‘后随机’探索以产生(而不是检验)假设；(8)准确阐述待测试的治疗策略并使用相应的适当设计；(9)扩大对研究人员和审查员进行随机对照试验原则培训的机会；(10)更加重视数据共享。神经精神药理学(2010年)35,2491-2501；DOI：10.1038/npp.2010.115；2010年8月25日在线发布
At the 2008 annual meeting of the American College of Neuropsychopharmacology (ACNP), a symposium was devoted to the following question: 'what have we learned about the design of pragmatic clinical trials (PCTs) from the recent costly long-term, large-scale trials of psychiatric treatments?' in order to inform the design of future trials. In all, 10 recommendations were generated placing emphasis on (1) appropriate conduct of pragmatic trials; (2) clinical, rather than, merely statistical significance; (3) sampling from the population clinicians are called upon to treat; (4) clinical outcomes of patients, rather than, on outcome measures; (5) use of stratification, controlling, or adjusting when necessary and not otherwise; (6) appropriate consideration of site differences in multisite studies; (7) encouragement of 'post hoc' exploration to generate (not test) hypotheses; (8) precise articulation of the treatment strategy to be tested and use of the corresponding appropriate design; (9) expanded opportunity for training of researchers and reviewers in RCT principles; and (10) greater emphasis on data sharing. Neuropsychopharmacology (2010) 35, 2491-2501; doi:10.1038/npp.2010.115; published online 25 August 2010