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

IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY International Journal of Gynecological Cancer Pub Date : 2024-09-13 DOI:10.1136/ijgc-2024-005751
Bhavana Pothuri, Premal Thaker, Adrienne Moore, Rosa Espinosa, Kara Medina, Deborah Collyar, Kathleen Lutz, Mihaela C Munteanu, Brian Slomovitz
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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 physician, advanced practice nurse, patient navigator, patient advocate, and pharmaceutical industry representation. 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 from 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.
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改善临床试验中不同患者的入组情况,重点关注西班牙裔和亚裔人群:跨学科专家小组的建议
临床试验注册患者缺乏多样性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缺乏普遍性、治疗机会不公平以及少数群体和弱势群体之间的健康差异。我们召集了一个多学科专家小组,以审议多样化患者累积所面临的挑战,并提供可行的解决方案来提高临床试验的代表性。该小组由具有妇科肿瘤学知识的人员组成,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业代表。重点讨论了亚裔和西班牙裔患者的招募障碍。专家小组确定了几个值得关注的领域,包括医生和护理团队的显性和隐性偏见、语言和文化上的细微差别、决策过程中未充分考虑家庭因素以及女性在临床试验中的代表性不足。专家小组还指出了患者导航员、护士和高级医疗服务提供者在招募代表性不足人群患者方面的重要作用。研究赞助商的作用以及全球和地区性倡议对于解决临床试验招募中的历史性差异也至关重要。所提出的可行解决方案应能帮助研究赞助商和临床试验机构在全球范围内实现更大程度的多元化招募。
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来源期刊
CiteScore
6.60
自引率
10.40%
发文量
280
审稿时长
3-6 weeks
期刊介绍: The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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