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":"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。","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":"{\"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}","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}
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023
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.
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.
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