不十分な力を持つ臨床試験の継続的な非倫理的な実施
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
まとめ
十分な臨床試験が実施されていないことは,依然として論争の的だ. それらは,計画されたメタ分析または早期段階の薬剤/デバイス開発を有する希少疾患に対してのみ倫理的であり,参加者の間接的な利益の開示を必要とする.
科学分野:
- 臨床研究の倫理について
- バイオ統計学 バイオ統計学
- 医学研究方法論 医学研究方法論
背景:
- 不十分な臨床試験に対する批判は続いているが,臨床試験の実施は増加している.
- 小規模な研究を支持する議論には,メタアナリシスの可能性と信頼区間の推定が含まれます.
- 倫理的懸念と,十分な力のない試験における参加者の自律性は,慎重に検討する必要があります.
研究 の 目的:
- 能力不足の臨床試験の倫理的正当性を検証する.
- 小規模な研究を支持する議論の妥当性をメタ分析と信頼区間を通じて評価する.
- 能力不足の試験を実施するための倫理的条件を定義する.
主な方法:
- 能力不足の臨床試験の倫理的分析.
- 小規模研究のメタ解析と信頼区間に関する議論のレビュー.
- 試験参加者に対する開示要求の検討.
主要な成果:
- 能力不足の試験は,限られた状況下で倫理的に許容されます.
- 理由付けは,希少疾患の将来的なメタアナリシス計画,または特定の初期段階の開発目標に基づいています.
- 参加者は,潜在的利益の間接的な性質について知らされなければならない.
結論:
- 能力不足の試験を倫理的に正当化するシナリオは2つしかありません:計画されたメタアナリシスを伴う希少疾患試験,非比較的なパワー目標を持つ初期段階の試験です.
- 間接的な利益に関する透明性は,情報に基づいた同意を得る上で極めて重要です.
- この慣習は,厳格な倫理的な監督と明確なコミュニケーションを必要とします.
キーワード:
生物医学および行動研究
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