Demographic comparison of subjects in FDA approval trials in the United States to disorder specific demographics using Real World Data

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-04-04 DOI:10.1016/j.conctc.2024.101293

Stephen J. Peroutka

引用次数: 0

Abstract

The Food and Drug Administration (FDA) has recommended that clinical trial study populations accurately reflect the patients likely to use the product, if approved. The FDA has not provided specific guidance on how cohort sizes of clinically relevant demographic characteristics should be determined. Therefore, the present study was designed to compare demographic characteristics reported in US-only FDA approval trials to the demographic characteristics of the related medical disorders in an electronic health records database of >150 M patients in the United States (US). The results demonstrate that comparative disparities in demographic cohort proportions are common, yet inconsistent, and highlight the need to define disorder specific demographic cohort proportion goals in future clinical trials.

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利用真实世界数据将美国 FDA 批准试验中的受试者与特定疾病的受试者进行人口统计学比较

美国食品和药物管理局（FDA）建议，临床试验研究人群应准确反映产品获批后可能使用的患者。FDA 并未就如何确定临床相关人口统计学特征的队列规模提供具体指导。因此，本研究旨在将仅在美国进行的 FDA 批准试验中报告的人口统计学特征与美国 150 万患者电子健康记录数据库中相关疾病的人口统计学特征进行比较。研究结果表明，人口统计群组比例的比较差异很常见，但并不一致，这突出表明在未来的临床试验中需要确定特定疾病的人口统计群组比例目标。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.