Regulatory landscape with U.S. patient requirements and Clinical Trial Diversity expectations

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-07-06 DOI:10.1016/j.conctc.2024.101331

Elizabeth George , Alicia Baker McDowell , Melissa Vozza , Talley Mitchell , Ben Quartley , Cassandra S. Kennedy , Bill Hanlon

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Abstract

The Food and Drug Administration (FDA) has an expectation that products filed for marketing authorization have to include data that are representative of the US patient population. Any foreign clinical data that is submitted has to represent an ethnically diverse population that is generated utilizing qualified Principal Investigators (PIs) and conducted according to Good Clinical Practices (GCP) requirements outlined in 21 CFR 312.120, Foreign clinical studies not conducted under an IND. With the recent passing of the Omnibus Legislation, FDA now also has the authority to require Diversity Plans for all Phase 3 clinical trials of new drugs or “as appropriate, another pivotal study of a new drug.” The FDA has released a guidance document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” (April 2022), for the industry with expectations to update the document in 2023 now that legislation is passed. This whitepaper discusses the FDA guidance and expectations of sponsors with regards to foreign clinical data and the intersection with enrolling ethnically diverse populations in clinical studies.

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美国患者要求和临床试验多样性期望的监管环境

美国食品和药物管理局 (FDA) 要求申请上市许可的产品必须包含能代表美国患者群体的数据。提交的任何国外临床数据必须代表不同种族的人群，这些数据必须由合格的主要研究者 (PI) 生成，并按照 21 CFR 312.120（非 IND 下进行的国外临床研究）中概述的良好临床实践 (GCP) 要求进行。随着最近综合立法的通过，FDA 现在还有权要求所有新药 3 期临床试验或 "酌情要求新药的另一项关键研究 "实施多样性计划。FDA 已为业界发布了一份指导文件《改善临床试验中代表性不足的种族和民族参与者的多元化计划》（2022 年 4 月），并预计在立法通过后于 2023 年更新该文件。本白皮书讨论了 FDA 的指导意见和申办者对国外临床数据的期望，以及在临床研究中招募不同种族人群的交叉问题。

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.