プラセボ対照試験とヘルシンキ宣言
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
まとめ
ヘルシンキ宣言は医学倫理を指針としているが,その厳格な解釈は,プラセボ対照試験を制限する可能性がある. プラセボの賢明な使用は,一部の新薬の有効性を確立するために依然として不可欠です.
科学分野:
- 医療倫理 医療倫理について
- クリニック・リサーチ 臨床研究
背景:
- ヘルシンキ宣言は,医学研究の倫理的指針を定めている.
- 2000年10月に改訂版が発行されました.
研究 の 目的:
- 臨床試験におけるプラセボ対照薬の使用の倫理的意味を検証する.
- 薬剤の有効性を確立するためにプラセボコントロールの必要性を評価する.
主な方法:
- 管理グループに関するヘルシンキ宣言のガイドラインの分析.
- プラセボ対照が不可欠であるとみなされるシナリオのレビューと,アクティブ対照を必要とするシナリオのレビュー.
主要な成果:
- 宣言の厳格な解釈は,有効な治療法が存在する場合,プラセボコントロールを回避することを示唆しています.
- しかし,新しい治療薬の有効性を実証するために,時にはプラセボ対照が不可欠である.
結論:
- 臨床試験におけるプラセボコントロールの倫理的使用は,慎重に検討する必要があります.
- 倫理的指針と,確固たる科学的証拠の必要性をバランスとすることが,医学進歩にとって極めて重要です.
キーワード:
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