臨床試験の結果をclinicalTrials.govで報告する法的要件の遵守:コホート研究
Nicholas J DeVito1, Seb Bacon1, Ben Goldacre1
1The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Lancet (London, England)
|January 21, 2020
まとめ
2007年の食品医薬品局改正法 (FDAAA) による臨床試験結果の報告は不十分であり,試験の40.9%だけが1年の期限を満たしている. 規制の執行とスポンサー措置の必要性を示しています.
科学分野:
- 臨床試験の透明性について
- 研究における規制の遵守
- 根拠に基づいた医療
背景:
- 臨床試験の結果を報告しないことは,証拠基盤を歪め,研究資源を無駄にします.
- 2007年の食品医薬品局改正法 (FDAAA) は,試験終了後1年以内にClinicalTrials.govで試験結果の報告を義務付けています.
- FDAAA最終規則の対象となる最初の試験は,2018年1月に報告される予定でした.
研究 の 目的:
- 臨床試験結果の報告に関するFDAAA 2007年最終規則の遵守を評価する.
- 試験の特徴を特定し,結果の提出を迅速にすること.
- トレンドとスポンサーレベルでの報告要求の遵守を検証する.
主な方法:
- 2018年3月から2019年9月までのClinicalTrials.govのデータを分析したコホート研究.
- 適用できない試験または報告が遅れた試験を除いて,FDAAAに基づく報告結果によるすべての適用可能な試験を含める.
- ロジスティック回帰とKaplan- Meier方法を使用して,準拠,関連因子,および報告までの時間を評価した.
主要な成果:
- 適用可能な治験の40. 9%だけが1年間の期限内に結果を報告し,63. 8%がいつでも結果を提出した.
- 順守率は2018年7月から改善されず,平均遅延は424日でした.
- 産業のスポンサーや多くの試験を運営する組織は 順守率が著しく高いことを示しました
結論:
- 臨床試験結果の報告に関するFDAAA 2007年最終規則の遵守は容認できないほど低く,改善していない.
- 規制の執行が不十分であることが 遵守の不十分な理由である可能性が高い.
- 透明性を高めるために,スポンサーの遵守の強化と公的監査が必要である.
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