Nature Medicine ( IF 58.7 ) Pub Date : 2024-10-14 , DOI: 10.1038/s41591-024-03273-3 Faiez Zannad, Otavio Berwanger, Stefano Corda, Martin R. Cowie, Habib Gamra, C. Michael Gibson, Alexandra Goncalves, Thomas Hucko, Kamlesh Khunti, Maciej Kostrubiec, Bettina Johanna Kraus, Cecilia Linde, Thomas F. Lüscher, Marion Mafham, Richard Mindham, Rebecca F. Ortega, Eva Prescott, Lehana Thabane, Clyde Yancy, André Ziegler, Harriette G. C. Van Spall
Cardiovascular clinical trials continue to under-represent children, older adults, females and people from ethnic minority groups relative to population disease distribution. Here we describe strategies to foster trial representativeness, with proposed actions at the levels of trial funding, design, conduct and dissemination. In particular, trial representativeness may be increased through broad recruitment strategies and site selection criteria that reflect the diversity of patients in the catchment area, as well as limiting unjustified exclusion criteria and using pragmatic designs that minimize research burden on patients (including embedded and decentralized trials). Trial communications ought to be culturally appropriate; engaging diverse people with lived experience in the co-design of some trial elements may foster this. The demographics of trialists themselves are associated with participant demographics; therefore, trial leadership must be actively diversified. Funding bodies and journals increasingly require the reporting of sociodemographic characteristics of trial participants, and regulatory bodies now provide guidance on increasing trial diversity; these steps may increase the momentum towards change. Although this Perspective focuses on the cardiovascular trial context, many of these strategies could be applied to other fields.
中文翻译:
如何使心脏病学临床试验更具包容性
相对于人口疾病分布,心血管临床试验仍然不足儿童、老年人、女性和少数民族群体。在这里,我们描述了促进试验代表性的策略,并在试验资金、设计、实施和传播层面提出了行动。特别是,可以通过反映服务区患者多样性的广泛招募策略和地点选择标准,以及限制不合理的排除标准和使用务实的设计来减少患者的研究负担(包括嵌入式和分散式试验),从而提高试验的代表性。庭审沟通应符合文化背景;让具有生活经验的不同人参与一些试验元素的共同设计可能会促进这一点。试验者本身的人口统计数据与参与者的人口统计数据有关;因此,试验领导必须积极多元化。资助机构和期刊越来越多地要求报告试验参与者的社会人口学特征,监管机构现在为增加试验多样性提供指导;这些步骤可能会增加变革的势头。尽管本观点侧重于心血管试验背景,但其中许多策略可以应用于其他领域。