小児専用プログラムで実施された臨床試験の経済的利益
Jennifer S Li1, Eric L Eisenstein, Henry G Grabowski
1Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, NC 27705, USA. jennifer.li@duke.edu
JAMA
|February 8, 2007
まとめ
Pediatric Exclusivity Programは,小児臨床試験を完了した製薬会社に対して,変動する経済的リターンを提供しています. いくつかの試行は大きな利益をもたらしますが,他の試行はより控えめな投資収益を提供します.
科学分野:
- 医薬品政策について
- 小児科の臨床試験について
- 薬物開発経済学 薬物開発経済学
背景:
- 米国食品医薬品局 (FDA) の小児独占プログラム (Pediatric Exclusivity Program) は,小児試験の完了のために6ヶ月のマーケティング延長を許可しています.
- このプログラムは小児科の研究を奨励しているが,製薬業界への金銭的利益に関する批判に直面している.
研究 の 目的:
- "小児独占プログラム"に参加している製薬会社の経済的収益を定量化する.
- FDAが要求する小児臨床試験の完了による財政的影響を評価する.
主な方法:
- コホート研究では,小児専用薬が認められた9種類の薬剤を分析した.
- 小児臨床試験の費用は,課税後の現金流出として推定されました.
- 市場販売は,6ヶ月の独占延長からの税後の現金流入を推定するために予測されました.
主要な成果:
- 経済収益は幅広く変化し,純収益は - 890万ドルから 5億790万ドルまでだった.
- 収益率比率も -0.68から73.63.3までの大幅な変動を示した.
- 研究された症状には,喘息,ADHD,がん,糖尿病などが含まれていました.
結論:
- 小児専用薬は,小児臨床試験を実施するための変動する経済的インセンティブを提供します.
- このプログラムは,非常に有利な結果をもたらしたり,薬剤のスポンサーにとってより限られた収益をもたらしたりすることができます.
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