Georgia Karanasiou, Elazer Edelman, Francois-Henri Boissel, Robert Byrne, Luca Emili, Martin Fawdry, Nenad Filipovic, David Flynn, Liesbet Geris, Alfons Hoekstra, Maria Cristina Jori, Ali Kiapour, Dejan Krsmanovic, Thierry Marchal, Flora Musuamba, Francesco Pappalardo, Lorenza Petrini, Markus Reiterer, Marco Viceconti, Klaus Zeier, Lampros K Michalis, Dimitrios I Fotiadis
{"title":"推进硅学临床试验，促进法规采纳和创新。","authors":"Georgia Karanasiou, Elazer Edelman, Francois-Henri Boissel, Robert Byrne, Luca Emili, Martin Fawdry, Nenad Filipovic, David Flynn, Liesbet Geris, Alfons Hoekstra, Maria Cristina Jori, Ali Kiapour, Dejan Krsmanovic, Thierry Marchal, Flora Musuamba, Francesco Pappalardo, Lorenza Petrini, Markus Reiterer, Marco Viceconti, Klaus Zeier, Lampros K Michalis, Dimitrios I Fotiadis","doi":"10.1109/JBHI.2024.3486538","DOIUrl":null,"url":null,"abstract":"<p><p>The evolution of information and communication technologies has affected all fields of science, including health sciences. However, the rate of technological innovation adoption by the healthcare sector has been historically slow, compared to other industrial sectors. Innovation in computer modeling and simulation approaches has changed the landscape in biomedical applications and biomedicine, paving the way for their potential contribution in reducing, refining, and partially replacing animal and human clinical trials. In Silico Clinical Trials (ISCT) allow the development of virtual populations used in the safety and efficacy testing of new drugs and medical devices. This White Paper presents the current framework for ISCT, the role of in silico medicine research communities, the different perspectives (research, scientific, clinical, regulatory, standardization, data quality, legal and ethical), the barriers, challenges, and opportunities for ISCT adoption. In addition, an overview of successful ISCT projects, market-available platforms, and FDA- approved paradigms, along with their vision, mission and outcomes are presented.</p>","PeriodicalId":13073,"journal":{"name":"IEEE Journal of Biomedical and Health Informatics","volume":"PP ","pages":""},"PeriodicalIF":6.7000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Advancing In Silico Clinical Trials for Regulatory Adoption and Innovation.\",\"authors\":\"Georgia Karanasiou, Elazer Edelman, Francois-Henri Boissel, Robert Byrne, Luca Emili, Martin Fawdry, Nenad Filipovic, David Flynn, Liesbet Geris, Alfons Hoekstra, Maria Cristina Jori, Ali Kiapour, Dejan Krsmanovic, Thierry Marchal, Flora Musuamba, Francesco Pappalardo, Lorenza Petrini, Markus Reiterer, Marco Viceconti, Klaus Zeier, Lampros K Michalis, Dimitrios I Fotiadis\",\"doi\":\"10.1109/JBHI.2024.3486538\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The evolution of information and communication technologies has affected all fields of science, including health sciences. However, the rate of technological innovation adoption by the healthcare sector has been historically slow, compared to other industrial sectors. Innovation in computer modeling and simulation approaches has changed the landscape in biomedical applications and biomedicine, paving the way for their potential contribution in reducing, refining, and partially replacing animal and human clinical trials. In Silico Clinical Trials (ISCT) allow the development of virtual populations used in the safety and efficacy testing of new drugs and medical devices. This White Paper presents the current framework for ISCT, the role of in silico medicine research communities, the different perspectives (research, scientific, clinical, regulatory, standardization, data quality, legal and ethical), the barriers, challenges, and opportunities for ISCT adoption. In addition, an overview of successful ISCT projects, market-available platforms, and FDA- approved paradigms, along with their vision, mission and outcomes are presented.</p>\",\"PeriodicalId\":13073,\"journal\":{\"name\":\"IEEE Journal of Biomedical and Health Informatics\",\"volume\":\"PP \",\"pages\":\"\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"IEEE Journal of Biomedical and Health Informatics\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1109/JBHI.2024.3486538\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"COMPUTER SCIENCE, INFORMATION SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"IEEE Journal of Biomedical and Health Informatics","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1109/JBHI.2024.3486538","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"COMPUTER SCIENCE, INFORMATION SYSTEMS","Score":null,"Total":0}
Advancing In Silico Clinical Trials for Regulatory Adoption and Innovation.
The evolution of information and communication technologies has affected all fields of science, including health sciences. However, the rate of technological innovation adoption by the healthcare sector has been historically slow, compared to other industrial sectors. Innovation in computer modeling and simulation approaches has changed the landscape in biomedical applications and biomedicine, paving the way for their potential contribution in reducing, refining, and partially replacing animal and human clinical trials. In Silico Clinical Trials (ISCT) allow the development of virtual populations used in the safety and efficacy testing of new drugs and medical devices. This White Paper presents the current framework for ISCT, the role of in silico medicine research communities, the different perspectives (research, scientific, clinical, regulatory, standardization, data quality, legal and ethical), the barriers, challenges, and opportunities for ISCT adoption. In addition, an overview of successful ISCT projects, market-available platforms, and FDA- approved paradigms, along with their vision, mission and outcomes are presented.
期刊介绍：
IEEE Journal of Biomedical and Health Informatics publishes original papers presenting recent advances where information and communication technologies intersect with health, healthcare, life sciences, and biomedicine. Topics include acquisition, transmission, storage, retrieval, management, and analysis of biomedical and health information. The journal covers applications of information technologies in healthcare, patient monitoring, preventive care, early disease diagnosis, therapy discovery, and personalized treatment protocols. It explores electronic medical and health records, clinical information systems, decision support systems, medical and biological imaging informatics, wearable systems, body area/sensor networks, and more. Integration-related topics like interoperability, evidence-based medicine, and secure patient data are also addressed.
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