了解参与美国生物制药赞助的临床试验招募工作的临床研究利益相关者的组织观点：关于改善临床研究可及性和包容性的组织举措的建议。
Understanding organizational perspectives from clinical research stakeholders involved in recruitment for biopharmaceutical-sponsored clinical trials in the United States: Recommendations for organizational initiatives to improve access and inclusivity in clinical research.
作者信息
Johnson Rebecca R, D'Abundo Michelle L, Cahill Terrence F, DeLuca Deborah A
机构信息
Global Patient and Site Solutions, IQVIA, 100 IMS Drive, Parsippany, NJ, 07054, USA.
Department of Interprofessional Health Sciences and Health Administration, School of Health and Medical Sciences, Seton Hall University, 123 Metro Boulevard, Nutley, NJ, 07110, USA.
出版信息
Contemp Clin Trials Commun. 2023 May 18;33:101148. doi: 10.1016/j.conctc.2023.101148. eCollection 2023 Jun.
BACKGROUND
Equitable representation of racially and ethnically diverse subpopulations in clinical trials continues to be a problem, and trial participants do not always reflect the demographics of the population that the investigational product will be used to treat. The imperativeness of equitable representation of clinically relevant populations in clinical trials has implications for improving health outcomes, increasing knowledge about the safety and efficacy of new treatments across a wider population, and broadening access to innovative treatment options offered in clinical trials.
METHODS
The purpose of this study was to understand organizational elements that are involved in the active implementation of racially and ethnically diverse inclusive recruitment practices for biopharmaceutical-funded trials in the United States. Semi-structured, in-depth interviews were used in this qualitative study. The interview guide was designed to explore the perceptions, practices and experiences of 15 clinical research site professionals related to recruiting diverse trial participants. Data analysis utilized an inductive coding process.
RESULTS
Five themes were identified pertaining to the actual implementation of inclusive recruitment practices that provided explanations for organizational components: 1) provision of culturally appropriate, general disease and clinical trial education 2) organizational structure tailored for diverse recruitment 3) strong sense of mission related to improving healthcare through clinical research 4) culture of inclusion 5) inclusive recruitment practices evolving based on learning.
CONCLUSION
The findings from this study offer insight into improving access to clinical trials by focusing on organizational change initiatives.
背景
临床试验中种族和民族多样化亚人群的公平代表性仍然是一个问题，试验参与者并不总是反映研究产品将用于治疗的人群的人口统计学特征。临床试验中临床相关人群公平代表性的紧迫性对于改善健康结果、增加关于新治疗方法在更广泛人群中的安全性和有效性的知识以及扩大获得临床试验中提供的创新治疗选择的机会具有重要意义。
方法
本研究的目的是了解在美国生物制药资助的试验中积极实施种族和民族多样化的包容性招募做法所涉及的组织要素。本定性研究采用半结构化深度访谈。访谈指南旨在探讨15名临床研究站点专业人员在招募不同试验参与者方面的看法、做法和经验。数据分析采用归纳编码过程。
结果
确定了与包容性招募做法的实际实施相关的五个主题，这些主题为组织组成部分提供了解释：1）提供文化上适当的、一般疾病和临床试验教育；2）为多样化招募量身定制的组织结构；3）通过临床研究改善医疗保健的强烈使命感；4）包容文化；5）基于学习不断发展的包容性招募做法。
结论
本研究结果通过关注组织变革举措，为改善临床试验的可及性提供了见解。
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