臨床試験登録におけるデータ共有計画の実践と,登録されたデータ共有計画と公表されたデータ共有計画の一致性:横断的な研究
Jingyi Zhang1, Barbara E Bierer2,3, Harriette G C Van Spall4,5,6
1Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, Guangdong, 510317, China.
BMC medicine
|September 2, 2025
まとめ
ほとんどの臨床試験では 登録時にデータ共有の計画が定められていない. 公開された試験の半分以上が,登録されたデータ共有計画と実際のデータ共有計画との間に不一致を示し,報告と信頼性の改善の必要性を強調しています.
科学分野:
- 臨床試験
- データ共有
- 研究の誠実さ
背景:
- 国際医学雑誌編集者委員会 (ICMJE) は,試験登録と出版の際にデータ共有計画を明記することを推奨しています.
- これらのデータ共有計画の採用と一貫性は不明である.
- この研究では,試験登録プラットフォームのデータ共有計画と公表された計画との一致を評価しています.
研究 の 目的:
- 臨床試験登録におけるデータ共有計画の普及率を評価する.
- 登録されたデータ共有計画と公表されたデータ共有計画の一致性を評価する.
- データ共有プランの登録と一致性に関連する要因を特定する.
主な方法:
- 臨床試験プラットフォームに登録された6つの高インパクトジャーナルで2021-2023年に発表された臨床試験が含まれています.
- データ共有計画は,登録における"共有する計画"の回答に基づいて評価される.
- 登録された計画と公表された計画の一致性 (はい/はい,いいえ/いいえ)
- 単項分析では,試験の特徴とデータ共有計画/一致性との関連が検討された.
主要な成果:
- 登録された治験の44. 6%だけがデータを共有する予定でした.
- 薬物介入はデータ共有計画を登録する確率を高めました (OR=2.71).
- 公開された試験の半分以上 (57. 4%) が登録された計画と公表された計画の不一致を示した.
- COVID-19試験では,データ共有の一致率が低い (OR=0.59).
- 統計分析計画,研究プロトコル,分析コード,および個々の参加者のデータで顕著な不一致が認められた.
結論:
- 登録された臨床試験のほとんどは 特定のデータ共有計画がない.
- 公開された治験の半分以上が 登録されたデータと公表されたデータ共有の意図の不一致を示しています
- 臨床試験データ共有計画の報告の正確性と信頼性を向上させるためには,さらなる努力が不可欠です.
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