不確実性原理と業界が後援する研究
B Djulbegovic1, M Lacevic, A Cantor
1Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA. djulbebm@moffitt.usf.edu
Lancet (London, England)
|September 1, 2000
まとめ
臨床試験に対する製薬業界の資金提供は,バイアスを引き起こす可能性があります. 非営利団体の資金による研究は,不確実性原理をよりよく維持し,治療のより公正な比較を保証します.
科学分野:
- 臨床試験の方法論 臨床試験の方法論
- 医学研究の倫理 医学研究の倫理
- 製薬産業の監督 製薬産業の監督
背景:
- 製薬業界が後援するランダム化臨床試験 (RCT) は,潜在的なバイアスに対する精査に直面しています.
- 偏見は,好ましくない結果を持つ低品質の研究の選択的な報告または公表から生じることがあります.
- 不確実性原理は,治療の有効性に関して本当の不確実性がある場合にのみRCTを義務付けます.
研究 の 目的:
- 136件の発表されたRCTにおける不確実性原理の遵守を評価する.
- 資金源が臨床試験の質と不確実性原理の遵守に与える影響を分析する.
- 製薬業界が後援する研究における潜在的なバイアスを調査する.
主な方法:
- 不確実性原理の遵守について,多発性骨髄腫における136件のRCTを検証した.
- 標準治療に対する実験的治療を好む研究の割合を比較した.
- 資金源 (営利 vs 非営利) に基づいて試験の品質と遵守を分析しました.
主要な成果:
- 営利団体によって部分的にまたは完全に資金提供された試験は,より高い品質スコア (p=0.06) への傾向を示しました.
- 非営利団体が資金を提供した研究では,バランスがより良く維持された (47%対53%が新しい治療法を好む,p=0.608).
- 営利目的で資金提供された試験は,実験的治療に対する有意なバイアスを示した (74%対26%,p=0.004).
結論:
- 不確実性原理の違反は,製薬業界が後援する研究における報告されたバイアスを説明する可能性がある.
- 透明な報告と適切な比較コントロールを奨励することは,臨床試験のスポンサーにとって極めて重要です.
- 試験設計における均衡の確保は,偏見のない研究結果のために不可欠である.
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