Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.
Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.
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DOI：
10.1001/jamacardio.2022.0161
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发表时间：
2022-05-01
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影响因子：
24
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中科院分区：
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--
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尽管承受着不成比例的心力衰竭（HF）负担，但黑人和西班牙裔个体在HF临床试验中的代表性很差。临床试验中的代表性不足限制了这些人群的研究结果的普遍性，甚至可能在将试验数据转化为代表性不足的人群的护理时引入不确定性和犹豫。心力衰竭合作实验室是一个由利益相关者组成的联盟，旨在加强心力衰竭治疗的发展，一直致力于改善来自不同和历史上代表性不足的群体的患者的招募策略。尽管美国食品药品监督管理局和国立卫生研究院制定了旨在提高试验代表性的联邦政策，但试验入组与HF人群的种族和民族组成成比例的差距仍然存在。在美国招募人数有限的情况下增加试验全球化是这些模式的主要驱动力。代表性入学的其他障碍包括护理机会的不平等，参与的后勤问题，限制性入学标准和英语语言要求。改善多样化试验入组的策略包括有条不紊的研究设计和研究中心选择、研究领导和工作人员的多样化、资格标准的扩大、社区和患者的参与以及广泛的利益相关者的承诺。在当代HF试验中，多样化的试验入组不仅可行，而且可以有效地实现，以提高试验知识的普遍性和临床实践的转化。
Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups. Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at improving trial representation, gaps in trial enrollment proportionate to the racial and ethnic composition of the HF population have persisted. Increasing trial globalization with limited US enrollment is a major driver of these patterns. Additional barriers to representative enrollment include inequities in care access, logistical issues in participation, restrictive enrollment criteria, and English language requirements. Strategies for improving diverse trial enrollment include methodical study design and site selection, diversification of research leadership and staff, broadening of eligibility criteria, community and patient engagement, and broad stakeholder commitment. In contemporary HF trials, diverse trial enrollment is not only feasible but can be efficiently achieved to improve the generalizability and translation of trial knowledge to clinical practice.
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