持续的不道德行为不足的临床试验
Scott D Halpern1, Jason H T Karlawish, Jesse A Berlin
1Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 108 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104-6021, USA. shalpern@mail.med.upenn.edu
JAMA
|July 16, 2002
概括
没有足够的临床试验仍然存在争议. 它们仅对有计划的元分析或处于早期药物/设备开发阶段的罕见疾病具有伦理性,需要参与者披露间接收益.
科学领域:
- 临床研究伦理学
- 生物统计学 生物统计学
- 医学研究方法学 医学研究方法学
背景情况:
- 对不足的临床试验的批评仍然存在,但他们的实践正在增加.
- 支持小型研究的论点包括元分析潜力和信心区间估计.
- 在缺乏实力的试验中,道德问题和参与者的自主性需要仔细考虑.
研究的目的:
- 检查不足的临床试验的伦理理由.
- 通过元分析和信心区间来评估支持小型研究的论据的有效性.
- 定义进行不足试验的伦理条件.
主要方法:
- 缺乏能力的临床试验的伦理分析.
- 关于元分析和小型研究的置信区间的论点的审查.
- 审查对试验参与者的披露要求.
主要成果:
- 在有限的情况下,缺乏实力的试验在伦理上是允许的.
- 理由依赖于对罕见疾病或特定早期发展目标的前性元分析计划.
- 参与者必须被告知潜在利益的间接性质.
结论:
- 只有两个场景在伦理上证明了不足的试验:罕见疾病试验与计划的元分析和早期试验与非比较的权力目标.
- 关于间接利益的透明度对于知情同意至关重要.
- 这种做法需要严格的道德监督和明确的沟通.
关键词:
生物医学和行为研究研究.
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