合意文書の翻訳費用は包括的な臨床試験の登録を妨げています
Maria A Velez1, Beth A Glenn2,3,4,5, Maria Garcia-Jimenez1,2,6
1Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.
Nature
|August 2, 2023
まとめ
癌臨床試験の同意文書の翻訳費用は,英語能力が限られた患者の参加を妨げる可能性があります. 業界から資金提供を受けていない研究では,これらの患者の登録率と転用率が低いことが示されました.
科学分野:
- 腫瘍学
- 臨床試験
- 健康に関する公平性
背景:
- 代表が少ない人種や民族の患者は,米国のがん臨床試験に低率で参加しています.
- 限られた英語能力は,これらの患者集団の中で一般的であり,コミュニケーションの障壁を作り出す可能性があります.
研究 の 目的:
- 同意文書の翻訳費用が,英語の能力が限られている患者をがん臨床試験に含めるための障壁であるかどうかを調査する.
- 業界が支援する試験と,業界が支援しない試験における,英語能力が限られた患者の登録率と翻訳率を比較する.
主な方法:
- 大規模ながんセンターでの 12,000件以上の同意の分析です
- 業界が支援する研究と非業界が支援する研究における同意文書の翻訳と患者登録率の比較
- 翻訳された同意文書を必要とする患者の評価
主要な成果:
- 業界が後援する研究と比較して,英語能力が限られた患者の同意事件の割合はおよそ半分でした.
- 同意文書に署名した患者の間では,業界が後援しない研究に参加した患者の場合,文書が本来の言語に翻訳される確率は約半分でした.
- これは,研究スポンサーに基づくアクセスと翻訳サービスの大きな格差を示唆しています.
結論:
- 業界が支援しないがん研究における同意文書の翻訳に伴う費用は,患者の参加に重大な,変更可能な障壁となる可能性があります.
- 翻訳コストを削減することで 限られた英語能力を持つ患者の臨床研究への公平な参加を 改善できるでしょう
- 癌の臨床試験の多様性を高めるには,翻訳された同意文書の提供が不可欠です.
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