用安慰剂控制的试验和赫尔辛基宣言
John A Lewis1, Bertil Jonsson, Gottfried Kreutz
1Hatch Green Cottage, Chartham Hatch, Canterbury, Kent CT4 7LP, UK. john.lewis@clintrial.co.uk
Lancet (London, England)
|April 20, 2002
概括
赫尔辛基宣言指导医学伦理,但其严格的解释可能会限制安慰剂对照试验. 合理使用安慰剂对于确定一些新药的有效性至关重要.
科学领域:
- 医学伦理 医学伦理
- 临床研究 临床研究
背景情况:
- 赫尔辛基宣言为医学研究提供了伦理准则.
- 一个修订版于2000年10月发布.
研究的目的:
- 检查在临床试验中使用安慰剂对照的伦理影响.
- 评估安慰剂对照的必要性,以确定药物的疗效.
主要方法:
- 分析赫尔辛基宣言关于控制组的指导方针.
- 对场景的审查,其中安慰剂对照被认为是必不可少的,而不是需要主动对照的场景.
主要成果:
- 声明的严格解释表明,当有活性治疗方法存在时,应避免安慰剂对照.
- 然而,安慰剂对照有时对于证明新治疗剂的有效性至关重要.
结论:
- 在临床试验中使用安慰剂对照的伦理使用需要仔细考虑.
- 将道德准则与强有力的科学证据的需求相平衡,对于医学进步至关重要.
关键词:
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