Enhancing the Diversity of Participants in the WISDOM Clinical Trial: Practical Challenges and Ethical Implications

增强 WISDOM 临床试验参与者的多样性：实际挑战和伦理影响

• 批准号: 10367828
• 负责人: LAURA J ESSERMAN
• 金额: $ 16.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10367828
• 关键词: Address; Adoption; Anthropology; Anxiety; Attention; Bioethics; Breast Cancer Detection; Caring; Clinical Research; Clinical Trials; Collaborations; Communities; Data; Diagnosis; Diagnostic tests; Disease; Enrollment; Ethical Issues; Ethics; Feedback; Frequencies; Funding; Genomic medicine; Genomics; Geography; Goals; Gold; Harm Reduction; Health Benefit; Healthcare; Hispanics; Incidence; Individual; Interview; Investigation; Learning; Literature; Malignant Neoplasms; Mammographic screening; Mammography; Measures; Methods; Modality; Operative Surgical Procedures; Outcome; Participant; Patient-Focused Outcomes; Policies; Politics; Population; Population Heterogeneity; Practical trial; Pragmatic clinical trial; Process; Randomized; Recommendation; Regrets; Research; Research Design; Research Personnel; Risk; Risk Assessment; Site; Sociology; Surveys; Technology; Testing; Time; TimeLine; Woman; Work; base; behavior measurement; behavioral outcome; cancer health disparity; clinical care; clinical research site; clinical risk; cohort; cost; ethical legal social implication; ethnic diversity; experience; genomic data; high risk; implementation barriers; improved; innovation; insight; legal implication; malignant breast neoplasm; molecular pathology; parent grant; personalized approach; policy implication; population based; population health; pragmatic trial; precision medicine; preventive intervention; primary endpoint; psychologic; psychological outcomes; racial diversity; randomized trial; recruit; risk perception; routine screening; screening; social; social implication; standard of care; study population; trial comparing; uptake; volunteer; working group

Title: Enhancing the Diversity of Participants in the WISDOM Clinical Trial: Practical Challenges and Ethical Implications. Abstract This bioethics supplement request expands the work of our NCI-funded R01 Expanding the WISDOM Study’s Diversity, Reach, and Generalizability. WISDOM (Women Informed to Screen Depending on Measures of Risk) is a pragmatic trial comparing a risk-based approach to breast cancer screening—in which the frequency and modality of screening is dependent on a personalized risk calculation—against the gold standard of annual screening. The goal is to determine whether a personalized approach is as safe, less morbid, better accepted by women, encourages uptake of preventive interventions, and is of higher health care value (better outcomes at less cost psychologically, physically, and financially). The purpose of the parent grant (which sponsors the supplement) is to increase enrollment and enhance the diversity of the WISDOM study population in order to increase generalizability to the US population. The proposed supplement builds upon a unique interdisciplinary partnership between the WISDOM clinical trial team and a team of ELSI investigators funded by a separate NCI R01 to study the social and ethical implications of WISDOM, titled: Precision Genomics in the WISDOM Pragmatic Clinical Trial: An “Embedded" ELSI Study of Risk-based Breast Cancer Screening. This project uses empirical and normative bioethics methods to identify and analyze the ELSI (ethical, legal, and social implications) challenges of risk-based screening. The embedded ethics project is guided by an overarching objective: to understand the intersection of precision genomics screening with known cancer health disparities. The proposed bioethics supplement will facilitate and expand research on the ELSI issues that arise as the WISDOM trial continues to innovate and evolve in order to meet its recruitment and retention goals and its commitment to enhance inclusion of diverse populations. The new aims proposed for the supplement will expand upon this unique opportunity and will address critical emerging issues not included in our original study design. Our Specific Aims are: (1) To expand the Ethics Working Group to include representatives from WISDOM’s four new enhanced-diversity recruitment sites and to extend the Ethics Working Group through 2022, allowing the group to continue to offer advice to WISDOM stakeholders in real time; and (2) To elucidate the challenges of enrolling racially and ethnically diverse participants in the WISDOM trial by interviewing study decliners across the original clinical study sites along with newly added clinical sites selected to enhance diversity. The proposed supplement is significant because little is known about recruitment of diverse populations in fully online studies. WISDOM’s efforts to enhance diversity while maintaining a largely online approach to recruitment requires study. This research with decliners will not only fill a gap in the literature but also will be used to enhance WISDOM recruitment processes, improve participant experiences, and help achieve recruitment goals.

标题：提高WISDOM临床试验参与者的多样性：实践挑战和伦理 影响。 摘要 这一生物伦理学补充申请扩展了我们的NCI资助的R 01扩展WISDOM研究的 多样性，范围和普遍性。WISDOM（妇女被告知根据风险措施进行筛查） 是一项务实的试验，比较了基于风险的乳腺癌筛查方法， 筛查的方式取决于个性化的风险计算，而不是每年一次的黄金标准。 筛选我们的目标是确定个性化的方法是否安全，更少的病态，更好地接受 鼓励妇女采取预防性干预措施，并具有更高的保健价值（更好的结果 在心理上、身体上和经济上花费较少）。父母补助金的目的（资助 补充）是为了增加入组人数，提高WISDOM研究人群的多样性， 提高对美国人口的普遍性。拟议的补充建立在一个独特的跨学科 WISDOM临床试验团队和ELSI研究人员团队之间的合作伙伴关系， NCI R 01研究WISDOM的社会和伦理影响，标题为：WISDOM中的精确基因组学 实用的临床试验：基于风险的乳腺癌筛查的“嵌入式”ELSI研究。本项目采用 确定和分析ELSI（伦理的、法律的和社会的）的经验和规范生物伦理学方法 影响）的风险为基础的筛选的挑战。嵌入式道德操守项目的指导方针是 目的：了解精确基因组学筛查与已知癌症健康差异的交叉点。 拟议的生物伦理学补编将促进和扩大对环境和社会科学研究所出现的问题的研究， WISDOM试验不断创新和发展，以满足其招聘和保留目标， 致力于加强对不同人群的包容。为补充方案提出的新目标将 扩大这一独特的机会，并将解决我们最初的研究中没有包括的关键新问题 设计我们的具体目标是：（1）扩大道德工作小组的成员，包括 WISDOM的四个新的增强多样性招聘网站，并通过以下方式扩大道德工作组 2022年，允许该小组继续向WISDOM利益相关者提供真实的建议;以及（2）阐明 通过访谈研究招募种族和民族多样性参与者参与WISDOM试验的挑战 沿着新增加的临床研究中心， 多样性拟议的补充是重要的，因为很少有人知道招聘不同的 完全在线研究中的人群。WISDOM努力增强多样性，同时保持在线 招聘方式需要研究。这项对下降者的研究不仅填补了文献中的空白， 还将用于增强WISDOM招募流程，改善参与者体验，并帮助 实现招聘目标。