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首页> 外文期刊>Journal of the American Academy of Child and Adolescent Psychiatry >AACAP 2002 Research Forum: Placebo and Alternatives to Placebo in Randomized Controlled Trials in Pediatric Psychopharmacology.
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AACAP 2002 Research Forum: Placebo and Alternatives to Placebo in Randomized Controlled Trials in Pediatric Psychopharmacology.

机译：AACAP 2002研究论坛：小儿心理药理学的随机对照试验中的安慰剂和替代品。

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OBJECTIVE: : The use of placebo in the pediatric age group has come under increasing scrutiny. At the 2002 Annual Meeting of the American Academy of Child and Adolescent Psychiatry, the Academy's Workgroup on Research conducted a research forum. The purpose was to identify challenges and their solutions regarding the use of placebo in randomized controlled trials in pediatric psychopharmacology. METHOD: : Workgroups focused on problems and solutions in five areas: ethics and human subjects, research design and statistics, partnering with consumers, U.S. Food and Drug Administration and pharmaceutical industry perspectives, and psychosocial treatments. RESULTS: : In many but not all circumstances, inclusion of a placebo control is essential to meet the scientific goals of treatment outcome research. Innovative research designs; involvement of consumers in planning and implementing research; flexibility by industry, academia, the National Institutes of Health, and regulatory agencies acting in partnership; and concomitant use of evidence-based psychosocial services can and should assist in making placebo-controlled trials acceptable. CONCLUSIONS: : Properly designed placebo-controlled trials remain necessary, ethical, and feasible.
机译：目的：越来越多的儿童年龄组使用安慰剂。在美国儿童和青少年精神病学学会2002年年会上，该学会的研究工作组举办了一个研究论坛。目的是确定有关儿科心理药理学随机对照试验中使用安慰剂的挑战及其解决方案。方法：：工作组集中于五个领域的问题和解决方案：道德和人类主题，研究设计和统计，与消费者合作，美国食品药品监督管理局和制药行业的观点以及心理社会治疗。结果：在许多但不是全部情况下，纳入安慰剂对照对于达到治疗结果研究的科学目标至关重要。创新的研究设计;消费者参与计划和实施研究;行业，学术界，美国国立卫生研究院和监管机构合作时的灵活性;并结合使用循证的社会心理服务可以而且应该有助于使安慰剂对照试验可接受。结论：正确设计的安慰剂对照试验仍然是必要的，合乎道德的且可行的。

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