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FDA：多数抗肿瘤临床试验中可不设安慰剂对照组

2018-11-01 MedSci MedSci原创

临床试验安慰剂
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2018年8月，美国FDA药审中心CDER(Center for Drug Evaluation and Research)发布了关于血液系统恶性肿瘤和肿瘤疾病的临床双盲试验和安慰剂使用指南。FDA建议，在设计抗肿瘤随机、双盲临床试验时，仅在特定情况下，才需使用安慰剂对照。这一草案的颁布是基于在临床试验中使用安慰剂治疗肿瘤疾病，可能面对实际操作和伦理上的问题的考量。一、安慰剂广义的安慰剂不仅包括无

2018年8月，美国FDA药审中心CDER(Center for Drug Evaluation and Research)发布了关于血液系统恶性肿瘤和肿瘤疾病的临床双盲试验和安慰剂使用指南。FDA建议，在设计抗肿瘤随机、双盲临床试验时，仅在特定情况下，才需使用安慰剂对照。这一草案的颁布是基于在临床试验中使用安慰剂治疗肿瘤疾病，可能面对实际操作和伦理上的问题的考量。一、安慰剂广义的安慰剂不仅包括无药理活性的物质，还包括医疗处理以外的一切因素，利如视觉、听觉、触觉、味觉、语言、以及所有环境因素、外科操作、心理治疗或过程等。安慰剂本身没有任何治疗作用，由于患者对医生信任、患者自我暗示以及对某种药物疗效的期望等而起到缓解症状的作用。安慰剂效应有可能出现在各种临床背景下，但并不是所有接受安慰剂治疗的患者都会出现安慰剂效应。病症不同，衡量病症改善的指标也不同，所以安慰剂效应的操作性定义也不同。事实上，在不同研究中安慰剂效应的强度有很大差异，若干关于安慰剂效应的强度的元分析研究结果也很不一致。一些研究认为安慰剂效应非常弱甚至不存在，另一些研究则认为安慰剂效应是存在的, 但在不同临床背景下其强度有很

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    2018-11-05 amyloid

    #对照#

    0

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    2019-08-30 ay2000fy

    #对照组#

    0

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    2018-11-03 wleon8895

    #安慰剂#

    0

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    2018-11-03 guoyibin

    #安慰剂对照#

    0

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    2018-11-01 1e145228m78(暂无匿称)

    学习了，谢谢作者分享!

    0

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