臨床薬理学が臨床試験の多様性と包摂を 支援する方法
Michael Z Liao1, Aarti Sawant2, Brian Corrigan3
1Genentech, Inc., South San Francisco, California, USA.
Clinical and translational science
|August 26, 2025
まとめ
臨床試験の多様性を達成するには 臨床薬理学のツールを活用し 代表が少ない集団を対象にする必要があります このアプローチにより 将来の治療は 安全で効果的で 公平に実施されます
科学分野:
- 臨床薬理学
- 薬物開発
- 健康に関する公平性
背景:
- 初期臨床試験に 多様な集団を登録することは 課題です
- 多様性プランの開発には 戦略的実施が必要です
- 多様性および包摂性臨床薬理学リーダーシップグループ (D&I CPLG WG) とアメリカ臨床薬理学および治療学会 (ASCPT) は,これらの問題に取り組んだ.
研究 の 目的:
- 臨床試験への代表が不足している集団の参加を改善するための戦略を策定する.
- 臨床薬理学のツールと多様性計画に関するガイドラインを活用する.
- 業界,規制当局,学界の協力を促進する.
主な方法:
- 業界,規制当局,IQのスピーカーが参加したプレカンファレンスセッションです.
- 臨床試験における多様性と包摂に関する最新の講義とケーススタディ
- モデルインフォメーションドラッグ開発 (MIDD) とトランスレーション薬学を含む臨床薬理学の戦略に関する議論
主要な成果:
- この会議は,業界,学術界,規制当局の協力を得て成功しました.
- 代表が不足している集団と利益リスクの評価に関する重要な問題も取り上げられました.
- 臨床試験における人口統計学的および生物学的要因 (年齢,民族性,臓器機能障害,代謝,トランスポーター,薬物遺伝学) の評価に関する洞察が提供された.
結論:
- 臨床試験における多様性を達成することは,生態系全体の持続的な努力を必要とする複雑な課題です.
- 臨床薬理学者は 公平な医薬品開発への転換を導く上で 重要な役割を果たしています
- 公平性や地域社会への関与が成功に不可欠です
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