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提高临床试验中不同患者的入组率,重点关注西班牙裔和亚裔人群:一个跨学科专家小组的建议。

Improving diverse patient enrollment in clinical trials, focusing on Hispanic and Asian populations: recommendations from an interdisciplinary expert panel.

作者信息

Pothuri Bhavana, Thaker Premal, Moore Adrienne, Espinosa Rosa, Medina Kara, Collyar Deborah, Lutz Kathleen, Munteanu Mihaela C, Slomovitz Brian

机构信息

NYU Langone Health Perlmutter Cancer Center, New York, New York, USA.

Division of Gynecologic Oncology, Washington University School of Medicine, Saint Louis, Missouri, USA.

出版信息

Int J Gynecol Cancer. 2025 Jun;35(6):101875. doi: 10.1136/ijgc-2024-005751. Epub 2025 Apr 18.

DOI:10.1136/ijgc-2024-005751
PMID:39277183
Abstract

Lack of patient diversity in clinical trial enrollment remains an obstacle to achieving equitable healthcare outcomes. Under-representation has resulted in non-generalizable clinical knowledge, inequitable access to treatment, and health disparities among minority and disadvantaged groups. A multidisciplinary panel was convened to consider the challenges of diverse patient accrual and provide actionable solutions to improve representation in clinical trials. The panel was comprised of participants with knowledge in gynecologic oncology and included physicians, advanced practice nurses, patient navigators, patient advocates, and pharmaceutical industry representatives. Focus was given to recruitment barriers for Asian and Hispanic patients. The panel identified several areas of concern, including explicit and implicit biases for the physician and care teams, language and cultural nuances, inadequate inclusion of family in the decision-making process, and under-representation of women in clinical trials. The panel also identified the important role patient navigators, nurses, and advanced practice providers have in patient recruitment of under-represented populations. The role of study sponsors, and global and regional initiatives, to address historic disparities in clinical trial recruitment were also considered critical. The actionable solutions proposed should enable study sponsors and clinical trial sites to achieve greater diversity in enrollment globally.

摘要

临床试验招募中患者多样性的缺乏仍然是实现公平医疗结果的障碍。代表性不足导致临床知识无法推广、治疗机会不平等以及少数族裔和弱势群体之间的健康差距。一个多学科小组召开会议,审议了不同患者入组的挑战,并提供了可行的解决方案,以提高临床试验中的代表性。该小组由妇科肿瘤学领域的专业人士组成,包括医生、高级执业护士、患者导航员、患者权益倡导者和制药行业代表。重点关注亚洲和西班牙裔患者的招募障碍。该小组确定了几个关切领域,包括医生和护理团队的显性和隐性偏见、语言和文化细微差别、在决策过程中家庭参与不足以及临床试验中女性代表性不足。该小组还确定了患者导航员、护士和高级执业提供者在招募代表性不足人群方面的重要作用。研究赞助商以及全球和地区倡议在解决临床试验招募中的历史差异方面的作用也被认为至关重要。提出的可行解决方案应使研究赞助商和临床试验机构能够在全球范围内实现更高的入组多样性。

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