関連する実験動画
Updated: Jul 11, 2026
09:25
Assessment of Ultrasonic Vocalizations During Drug Self-administration in Rats
Published on: July 22, 2010
薬物有害事象および報告に関する研究 (RADAR) プロジェクト
Charles L Bennett1, Jonathan R Nebeker, E Allison Lyons
1Jesse Brown VA Medical Center/Mid-West Center for Health Services and Policy Research, Chicago, Ill 60611, USA. cbenne@northwestern.edu
JAMA
|May 5, 2005
まとめ
RADAR (Research on Adverse Drug Events And Reports) プログラムは,16件の重篤な副作用を特定し,患者の安全性を向上させました. この臨床的監視は,医薬品の安全性の監視を向上させるための既存のシステムを補完しています.
科学分野:
- 医薬品監視 医薬品監視
- クリニック・リサーチ 臨床研究
- 患者の安全性について
背景:
- 1998年に設立されたRADAR (Research on Adverse Drug Events And Reports) プログラムは,販売後の臨床監視のためのイニシアチブである.
- 組織は,これまで認識されていない深刻な薬物およびデバイスの副作用 (ADRs) に関する情報を体系的に調査し,普及させています.
研究 の 目的:
- RADARプロジェクトの構造,運用,初期発見について概要を述べる.
- 製薬サプライヤーとFDAを巻き込んだ広報活動について説明します.
主な方法:
- 重篤で予期せぬ臨床的イベントの仮説に基づく調査.
- 医師の問い合わせ,臨床試験,症例報告,FDAのデータベース,および販売数値からのデータ収集.
- 発生率の推定値の導出と仮説の実験室での支持.
主要な成果:
- RADARは1699人の患者で16種類の重度のADRを特定し,169人 (10%) が死亡しました.
- 複数のデータソースが症例の特定と発生率の推定に貢献しました.
- 配布には,改訂されたパッケージ挿入書",親愛なる医師"の手紙,ピアレビューされた記事が含まれていました.
結論:
- 市場投入後の監視に新しい,臨床的,仮説に基づいたアプローチが開発されました.
- この方法は,既存の規制監視システムを補完することができます.
- RADARプログラムは,患者の安全性を大幅に改善する可能性があります.
関連する概念動画
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