新薬やデバイスの評価における利益リスクトレードオフ
Sanjay Kaul1, Norman Stockbridge2, Javed Butler3
1Department of Cardiology, Cedars-Sinai Medical Center, and the David Geffen School of Medicine, University of California, Los Angeles (S.K.).
Circulation
|November 16, 2020
まとめ
医療介入の利益リスクの評価は 極めて重要です この論文では,情報に基づいた意思決定を支援するために,これらのプロフィールを評価し,伝えるための質的および定量的方法を探索します.
科学分野:
- 医療に関する意思決定
- 規制科学
- 健康経済学
背景:
- 医療上の利益とリスクのバランスをとることは 規制機関と臨床実践にとって大きな課題です
- 新薬や器具の有効な評価とリスクプロフィールの伝達は不可欠です.
研究 の 目的:
- 利益リスク評価の質的および定量的アプローチを記述する.
- 様々な治療の利益リスク評価の例を提示する.
主な方法:
- 質的アプローチ:利益リスクアクションチーム (BRAT) フレームワーク,利益リスクフレームワーク (BRF)
- 定量的なアプローチ:利益と害のための治療に必要な数 (NNT),利益リスク比 (BRR),インクリメンタル純利益 (INB).
- 例として,SGLT2阻害剤 (糖尿病),ダビガトラン (心房細動),TAVR (大動脈狭窄症),ヴォラパクサール/プラスグレル (心血管疾患) が挙げられる.
主要な成果:
- この論文では,利益リスクプロフィールを評価するための構造化された方法について概要を述べています.
- 様々な治療分野におけるこれらの方法の応用例を示しています.
- 利益リスク指標の不確実性を把握するのに役立ちます.
結論:
- 質的,定量的,または複合的なアプローチを用いた構造化された利益リスク評価は,透明性を高めます.
- 分かりやすいグラフィックは 臨床医と患者の間で 共有された意思決定を支援します
- これらの評価ツールの定期的な適用は,治療上の意思決定と規制上の評価を改善することができます.
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