臨床試験における臨床結果評価における患者参加負担の測定
Abigail Dirks1, Hana Do2, Chelsea Gallagher3
1Tufts Center for the Study of Drug Development, Boston, United States. abigail.dirks@tufts.edu.
Therapeutic innovation & regulatory science
|August 21, 2025
まとめ
臨床試験への参加の負担は評価の種類と期間によって異なります. 臨床結果の評価から患者と施設の負担を理解することで,試験の複雑さを減らすためにプロトコル設計に情報を与えることができます.
科学分野:
- 臨床試験の方法論
- 患者からの報告
- 医療サービス研究
背景:
- Bristol Myers Squibb (BMS),ZS,およびTufts CSDDは,臨床結果評価 (COA) に関する参加負担を評価した.
- この評価は,患者によって報告されたアウトカム (PRO) と臨床試験で使用された他のCOAに焦点を当てた.
研究 の 目的:
- 臨床試験における様々なCOAに関連する参加負担を評価する.
- 患者と調査現場の負担に寄与する要因を特定する.
- 臨床試験の設計における参加負担を軽減するための戦略を策定する.
主な方法:
- ミックス・メソッドのアプローチが採用された.
- 258人の患者を対象にオンラインで世界的な調査が行われました.
- 12人の患者と12人の調査現場のスタッフとの深入なインタビューが行われました.
主要な成果:
- 患者の負担の認識は,COAの形態とタイプによって著しく異なっていた.
- 30分以上のCOAまたは毎月複数回投与は,より高い負荷と関連していました.
- 患者の年齢,民族性,電子COAによる技術的な課題が 認知された負担に影響しました.
結論:
- 研究結果は,COAに関連する患者参加負担の認識を高めています.
- 臨床試験のプロトコルへの参加負担を 選択的に軽減するための決定を導く結果です
- この研究は タフツのCSDD-ZS患者負担アルゴリズムに基づいています
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