Olalekan Lee Aiyegbusi, Samantha Cruz Rivera, Paul Kamudoni, Nicola Anderson, Philip Collis, Alastair K. Denniston, Rosie Harding, Sarah E. Hughes, Kamlesh Khunti, Dipak Kotecha, Harlan Krumholz, Xiaoxuan Liu, Christel McMullan, Barbara Molony-Oates, Joao Monteiro, Puja Myles, Khadija Rerhou Rantell, Katherine Soltys, Ravinder Verdi, Roger Wilson, Melanie J. Calvert
{"title":"促进分散临床试验中的公平、多样性和包容性的建议","authors":"Olalekan Lee Aiyegbusi, Samantha Cruz Rivera, Paul Kamudoni, Nicola Anderson, Philip Collis, Alastair K. Denniston, Rosie Harding, Sarah E. Hughes, Kamlesh Khunti, Dipak Kotecha, Harlan Krumholz, Xiaoxuan Liu, Christel McMullan, Barbara Molony-Oates, Joao Monteiro, Puja Myles, Khadija Rerhou Rantell, Katherine Soltys, Ravinder Verdi, Roger Wilson, Melanie J. Calvert","doi":"10.1038/s41591-024-03323-w","DOIUrl":null,"url":null,"abstract":"Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data. While some studies have demonstrated the potential for these approaches to reduce barriers to clinical trial participation, they are associated with several challenges that may create or worsen existing health inequalities and limit the generalizability of trial results. Here we review the potential for digitally enabled and decentralized clinical trials to enhance clinical trial participation in an equitable manner. We describe the key barriers individuals from underserved groups may face, and provide recommendations to promote equity, diversity and inclusion. Digitally enabled and decentralized clinical trials could enable large-scale recruitment of diverse participants—but careful consideration of the barriers faced by underserved groups will be crucial to their success.","PeriodicalId":19037,"journal":{"name":"Nature Medicine","volume":"30 11","pages":"3075-3084"},"PeriodicalIF":58.7000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41591-024-03323-w.pdf","citationCount":"0","resultStr":"{\"title\":\"Recommendations to promote equity, diversity and inclusion in decentralized clinical trials\",\"authors\":\"Olalekan Lee Aiyegbusi, Samantha Cruz Rivera, Paul Kamudoni, Nicola Anderson, Philip Collis, Alastair K. Denniston, Rosie Harding, Sarah E. Hughes, Kamlesh Khunti, Dipak Kotecha, Harlan Krumholz, Xiaoxuan Liu, Christel McMullan, Barbara Molony-Oates, Joao Monteiro, Puja Myles, Khadija Rerhou Rantell, Katherine Soltys, Ravinder Verdi, Roger Wilson, Melanie J. Calvert\",\"doi\":\"10.1038/s41591-024-03323-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data. While some studies have demonstrated the potential for these approaches to reduce barriers to clinical trial participation, they are associated with several challenges that may create or worsen existing health inequalities and limit the generalizability of trial results. Here we review the potential for digitally enabled and decentralized clinical trials to enhance clinical trial participation in an equitable manner. We describe the key barriers individuals from underserved groups may face, and provide recommendations to promote equity, diversity and inclusion. Digitally enabled and decentralized clinical trials could enable large-scale recruitment of diverse participants—but careful consideration of the barriers faced by underserved groups will be crucial to their success.\",\"PeriodicalId\":19037,\"journal\":{\"name\":\"Nature Medicine\",\"volume\":\"30 11\",\"pages\":\"3075-3084\"},\"PeriodicalIF\":58.7000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.nature.com/articles/s41591-024-03323-w.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nature Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.nature.com/articles/s41591-024-03323-w\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nature Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.nature.com/articles/s41591-024-03323-w","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
Recommendations to promote equity, diversity and inclusion in decentralized clinical trials
Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data. While some studies have demonstrated the potential for these approaches to reduce barriers to clinical trial participation, they are associated with several challenges that may create or worsen existing health inequalities and limit the generalizability of trial results. Here we review the potential for digitally enabled and decentralized clinical trials to enhance clinical trial participation in an equitable manner. We describe the key barriers individuals from underserved groups may face, and provide recommendations to promote equity, diversity and inclusion. Digitally enabled and decentralized clinical trials could enable large-scale recruitment of diverse participants—but careful consideration of the barriers faced by underserved groups will be crucial to their success.
期刊介绍:
Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors.
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-Clinical trials, whether phase 1, 2, 3 or 4
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-Biomarker studies
-Public and global health studies
Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.