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臨床試験の登録に関する問題
Deborah A Zarin1, Nicholas C Ide, Tony Tse
1National Library of Medicine, National Institutes of Health, US Department of Health and Human Services, Bethesda, Md, USA. dzarin@mail.nih.gov
JAMA
|May 18, 2007
まとめ
完全な臨床試験報告の確保は極めて重要です. このレビューでは,臨床試験の登録システムと結果データベースを調査し,臨床試験の透明性を高めるため,データの正確性と公衆への普及に関する課題を強調しています.
科学分野:
- クリニック・トライアル・マネジメント
- バイオメディカル・インフォマティクス
- 公共衛生政策 公共衛生政策とは
背景:
- 臨床試験の結果の報告が不完全または遅れていることに対する公衆の懸念が高まっている.
- 臨床試験登録簿と結果データベースの役割に対する関心が高まっている.
研究 の 目的:
- 臨床試験登録の現状を見直す.
- 試験登録と結果報告のための包括的なシステムの確立における課題を特定する.
主な方法:
- 既存の臨床試験登録の取り組みとデータベースのレビュー.
- データ有効性,命名慣習,検索機能に関する課題の分析.
- 試験結果データベースに関する政策イニシアチブの検討.
主要な成果:
- ClinicalTrials.govは,140カ国から36,249件の臨床試験を登録した最大のレジストリです.
- 主な課題には,重複登録,明瞭な介入命名,効果的な検索機能などがあります.
- 試験結果データベースの開発は,データの要約形式と独立した科学的レビューなしの普及に障壁に直面しています.
結論:
- 臨床試験の登録と結果報告の改善には,技術的,政策的な課題に取り組む必要があります.
- 試験結果の公開には,標準化されたフォーマットとプロセスが必要です.
- データのアクセシビリティと科学的厳格性のバランスをとることは,信頼できる結果データベースにとって不可欠です.
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