新薬の臨床試験におけるアメリカ黒人の代表
1Department of Pharmaceutical Sciences, College of Pharmacy, Wayne State University, Detroit, MI 48202.
JAMA
|January 13, 1989
まとめ
臨床試験では,多くの場合,黒人アメリカ人が過小評価され,薬物の安全性および有効性に関するデータが制限されています. 研究参加におけるこの人種的格差は,公平な医療成果を確保するために,緊急に注意を払う必要があります.
科学分野:
- ファルマコゲノミクスとは
- 臨床研究の倫理について
- 健康の格差について
背景:
- 薬物反応における人種差異は,多様な臨床試験集団を必要とします.
- 大学病院の所在地によって,少数派が研究に従事する割合が不釣り合いになる可能性があります.
- 臨床薬剤試験に人種的少数派を公平に含めるという懸念がある.
研究 の 目的:
- 最近発表された臨床薬剤試験における黒人アメリカ人の代表性を評価する.
- 薬物反応の変動源として,人種差異が適切に考慮されているかどうかを判断する.
- 一般人口と比較して黒人被験者の不足の程度を評価する.
主な方法:
- 新薬を含む50件の最近発表された臨床試験のレビュー.
- 対象者の人口統計を分析し,特にアメリカの黒人参加者の割合に焦点を当てた.
- 対象者の割合を一般人口の人口統計データと比較.
主要な成果:
- 研究者は,薬物反応の変動に影響を与える要因として,しばしば人種的差異を無視します.
- レビューされた大半の研究では,黒人被験者の割合は,一般人口における黒人被験者の割合よりも低いことが示された.
- 多くの臨床試験において,黒人アメリカ人の有意な不足が観察されました.
結論:
- 臨床試験における黒人アメリカ人の不足は,この人口集団における薬物の安全性と有効性を評価するためのデータ不足につながります.
- 臨床研究における多様な人種集団の参加を向上させるには,重大な必要性があります.
- これらの格差を克服することは,パーソナライズド医療の進歩と,公平な薬物開発を確保するために不可欠です.
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