臨床試験のための科学的データ監査の成功したシステム. がんと白血病グループBからの報告
R B Weiss1, N J Vogelzang, B A Peterson
1Department of Medicine, Walter Reed Army Medical Center, Washington, DC 20307.
JAMA
|July 28, 1993
まとめ
癌および白血病グループB (CALGB) の臨床試験の現場監査は,希少な科学的不適切性と遵守の改善を示しています. 癌試験データの正確性と患者の安全管理は,時間の経過とともに著しく改善されています.
科学分野:
- 腫瘍学 腫瘍学
- クリニック・トライアル 臨床試験
- 医療監査 医療監査について
背景:
- 癌と白血病グループB (CALGB) は,がん治療の臨床試験を実施する協力グループです.
- ソース文書の現場監査は,臨床研究におけるデータの完全性と規制の遵守を確保するために極めて重要です.
研究 の 目的:
- CALGB内のソース文書の現場監査で収集されたデータについて報告する.
- 準拠の動向を評価し,臨床試験の実施を改善すべき分野を特定する.
主な方法:
- 4つの監査サイクル (1982年-1992年) の監査報告書を遡及的に検討する.
- CALGB臨床試験の患者を含む691件の機関監査の分析.
- 主要機関と関連機関CALGB間の準拠率の比較.
主要な成果:
- 機関審査委員会による監督の遵守は著しく改善され,欠陥率は28.0%から13.3% (メイン) と49.6%から28.2% (アフィリエイト) に低下した.
- 同意書の欠陥は18.5%から3.9%に減少した. 患者の適格性 (94.5%) と腫瘍応答評価 (96.4%) の検証は依然として高い.
- 科学的な不適切な行為は珍しい (0.28%),1984年以降の事例はありませんでした. 薬物投与における主要なプロトコル偏差は,約11%で安定したままでした.
結論:
- CALGBの臨床試験では,科学的な不適切性は稀である.
- 患者の適格性および腫瘍応答の評価における高度なプロトコル遵守.
- 現場監査は,行政のコンプライアンスと調査員のパフォーマンスの測定可能な改善をもたらしました.
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