Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-02-01 DOI:10.1016/j.biologicals.2024.101745

Marco Cavaleri , David Kaslow , Eric Boateng , Wilbur H. Chen , Christopher Chiu , Robert K.M. Choy , Rodrigo Correa-Oliveira , Anna Durbin , Moses Egesa , Malick Gibani , Melissa Kapulu , Melba Katindi , Ally Olotu , Pongphaya Pongsuwan , Michelo Simuyandi , Bruno Speder , Kawsar R. Talaat , Charlie Weller , Bridget Wills , Marc Baay , Pieter Neels

{"title":"Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023","authors":"Marco Cavaleri , David Kaslow , Eric Boateng , Wilbur H. Chen , Christopher Chiu , Robert K.M. Choy , Rodrigo Correa-Oliveira , Anna Durbin , Moses Egesa , Malick Gibani , Melissa Kapulu , Melba Katindi , Ally Olotu , Pongphaya Pongsuwan , Michelo Simuyandi , Bruno Speder , Kawsar R. Talaat , Charlie Weller , Bridget Wills , Marc Baay , Pieter Neels","doi":"10.1016/j.biologicals.2024.101745","DOIUrl":null,"url":null,"abstract":"<div><p>Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.</p></div>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000022/pdfft?md5=4b7ceed9d1cf2f1134b90121cff6902a&pid=1-s2.0-S1045105624000022-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105624000022","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}

引用次数: 0

Abstract

Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

第四次受控人类感染模型（CHIM）会议，CHIM 监管问题，2023 年 5 月 24 日。

受控人类感染模型（CHIM，又称人类挑战研究和人类感染研究）的许多方面已得到广泛讨论，包括挑战剂的良好生产规范（GMP）生产、CHIM 伦理学、CHIM 的环境安全、招募、社区参与、广告和激励措施、预先存在的免疫以及临床、免疫学和微生物学终点。第四次 CHIM 会议重点讨论了 CHIM 研究的监管问题，来自高、中、低收入国家的科学家和监管人员汇聚一堂，讨论了 CHIM 监管方面的障碍和阻碍。CHIM 监管方面已经采取了一些有价值的举措，但进一步的能力建设仍然至关重要。惠康考虑因素文件是进一步讨论的良好起点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.

期刊最新文献

Management of Cholesteatoma: Hearing Rehabilitation. Congenital Cholesteatoma. Evaluation of Cholesteatoma. Management of Cholesteatoma: Extension Beyond Middle Ear/Mastoid. Recidivism and Recurrence.