Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals Pub Date : 2025-01-17 DOI:10.1016/j.biologicals.2025.101818

Irina Meln , Victor Cnossen , Nicoletta Corti , Arno Andeweg , Marc Baay , Christopher Chiu , John Coia , Oliver Cornely , Rebecca J. Cox , Dileep Dasyam , Sigrid C.J. De Keersmaecker , Meagan Deming , Joanna Waldock , Othmar G. Engelhardt , Manman Guo , Okba Haj-Ali Saflo , Annefleur Hensen , Rienk Jeeninga , Simon Kolstoe , Oleg Krut , Ingrid M.C. Kamerling

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引用次数: 0

Abstract

Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs. Key discussions focused on refining trial protocols to balance statistical power with participant burden, overseen by a data safety monitoring board. The meeting emphasised the importance of harmonizing CHIM protocols to ensure robust, reproducible, and transparent research. Mandatory trial registration and adherence to the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles were recommended to enhance data reuse and scientific value. This report consolidates efforts to standardise CHIM protocols, essential for accelerating therapeutic innovations and advancing global health research.

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关于人体挑战研究临床程序、终点和数据稳健性标准化的监管研讨会-利益相关者会议报告。

Inno4Vac是由IMI2/EU/EFPIA联合事业（IMI2 JU）资助的一项公私伙伴关系，它汇集了学术机构、中小企业和制药公司，以加速疫苗开发并降低风险。该项目在流感、呼吸道合胞病毒（RSV）和产毒艰难梭菌的挑战剂的选择和生产方面取得了重大进展，用于控制人类感染模型研究（CHIMs）。2024年3月20日举行的监管研讨会讨论了临床程序的标准化、伦理考虑、终点和数据完整性，强调了与这些CHIMs相关的正在进行的举措。主要讨论的重点是完善试验方案，在数据安全监测委员会的监督下平衡统计权力与参与者负担。会议强调协调CHIM协议的重要性，以确保稳健、可重复和透明的研究。建议强制性试验注册和遵守可查找、可访问、可互操作和可重用（FAIR）数据原则，以增强数据重用和科学价值。本报告巩固了标准化CHIM协议的努力，这对加速治疗创新和推进全球卫生研究至关重要。

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

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

期刊介绍： Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.