视网膜静脉闭塞继发黄斑水肿的临床试验招募与真实世界人口统计学之间的差异。

IF 4.1 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2024-10-04 DOI:10.1016/j.ajo.2024.09.031

Theodore Bowe , Collin J. Richards , Hana A. Mansour , Ferhina S. Ali , Jayanth Sridhar , Jr Basil K. Williams , Yoshi Yonekawa , Michael N. Cohen , David Xu , Jordan D. Deaner , Meera Sivalingam , Anton Orlin , Shriji Patel , Ajay E. Kuriyan

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引用次数: 0

摘要

目的：临床试验队列的人口构成经常与接受治疗的总体人口构成不同。我们的研究描述了视网膜静脉闭塞（RVO）黄斑水肿（ME）临床试验队列的种族、民族和性别构成，并将其与（Intelligent Research in Sight）IRIS®注册中心继发于RVO的ME接受治疗患者的种族、民族和性别构成进行了比较：设计：回顾性观察病例系列研究对象：RVO-ME 研究的参与者：符合以下纳入标准的RVO-ME临床试验参与者：在美国进行，完成III期临床试验，2000年1月1日至2020年1月1日期间报告的数据，以及与结果一起报告的人口统计学信息：本研究通过以下检索词搜索 PubMed："视网膜静脉闭塞 "和 "临床试验"，以及以 "视网膜静脉闭塞 "为检索词搜索 ClinicalTrials.gov，从而确定临床试验：主要结果是入组比例，即试验入组人数除以IRIS® Registry (Intelligent Research in Sight)数据中接受ME治疗的RVO患者的参考样本量。比较了不同种族、族裔和性别之间的注册比例：结果：八项临床试验符合我们的纳入标准。与白人 7.69% 的注册比例相比，黑人患者（4.32%，几率比 [OR]0.541，置信区间 [CI]0.468-0.626，P< 0.001）和西班牙裔患者（3.38%，几率比 0.420，置信区间 0.351-0.503，P< 0.001）的注册比例较低：与接受RVO继发性ME治疗的人群相比，RVO-ME临床试验中亚裔、白人和男性受试者的比例相对较高。应进一步鼓励临床试验招募能够反映接受RVO-ME治疗的人群，以确保临床试验结果的普遍性。

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Disparities Between Clinical Trial Recruitment and Real-World Demographics in Macular Edema Secondary to Retinal Vein Occlusion

Purpose

Clinical trial cohorts frequently differ demographically from the overall population receiving treatment for the condition under study. Our study describes the racial, ethnic, and gender composition of the cohorts of retinal vein occlusion (RVO) macular edema (ME) clinical trials and compares this to the racial, ethnic, and gender composition of patients undergoing treatment for ME secondary to RVO from the (Intelligent Research in Sight) IRIS Registry.

Design

Retrospective observational case series Subjects: Participants in RVO-ME clinical trials that met the following inclusion criteria: conducted in the United States of America, Phase III completed, data reported between January 1, 2000, and January 1, 2020, and demographic information reported with results.

Methods

This study identified clinical trials by searching PubMed with the following search terms; “retinal vein occlusion” and “clinical trial” and by searching ClinicalTrials.gov with the search term “retinal vein occlusion.”

Main Outcome Measures

The primary outcome was the enrollment fraction defined as the number of trial enrollees divided by the reference sample size of RVO patients undergoing treatment for ME from published IRIS Registry (Intelligent Research in Sight) data. Enrollment fraction was compared between different races, ethnicities, and genders.

Results

Eight clinical trials met our inclusion criteria. Compared to the enrollment fraction of 7.69% among Whites, lower enrollment fractions were found in Black patients (4.32%, odds ratio [OR] 0.541, confidence interval [CI] 0.468-0.626, P < .001) and Hispanic patients (3.38%, OR 0.420, CI 0.351-0.503, P < .001), and higher enrollment fraction in Asian patients (10.68%, OR 1.436, CI 1.207-1.708, P < .001). Men were more likely to enroll in the clinical trials compared to women (enrollment fraction, 7.69% vs 5.77%, respectively, OR 1.364, CI 1.273-1.462, P < .001).

Conclusions

RVO-ME clinical trials have a higher relative proportion of Asian, White and male subjects when compared to the population undergoing treatment for ME secondary to RVO. Further efforts should encourage clinical trial recruitment that is reflective of the RVO population undergoing treatment for ME to ensure generalizability of clinical trial results.

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.