用于阿尔茨海默病研究的远程测量技术开发的监管考量

Regulatory considerations for developing remote measurement technologies for Alzheimer's disease research.

作者信息

Erdemli Gül, Grammatikopoulou Margarita, Wagner Bertil, Vairavan Srinivasan, Curcic Jelena, Aarsland Dag, Wittenberg Gayle, Nikolopoulos Spiros, Muurling Marijn, Froehlich Holger, de Boer Casper, Shanbhag Niraj M, Nies Vera J M, Coello Neva, Gove Dianne, Diaz Ana, Foy Suzanne, Dartee Wim, Brem Anna-Katharine

机构信息

Novartis Pharmaceuticals Corporation, Cambridge, MA, USA.

Information Technologies Institute, Centre for Research & Technology Hellas, Thessaloniki, Greece.

出版信息

NPJ Digit Med. 2024 Sep 4;7(1):232. doi: 10.1038/s41746-024-01211-8.

DOI:10.1038/s41746-024-01211-8

PMID:39232033

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11375004/

Abstract

The Remote Assessment of Disease and Relapse – Alzheimer’s Disease (RADAR-AD) consortium evaluated remote measurement technologies (RMTs) for assessing functional status in AD. The consortium engaged with the European Medicines Agency (EMA) to obtain feedback on identification of meaningful functional domains, selection of RMTs and clinical study design to assess the feasibility of using RMTs in AD clinical studies. We summarized the feedback and the lessons learned to guide future projects.

摘要

疾病与复发远程评估——阿尔茨海默病（RADAR-AD）联盟评估了用于评估阿尔茨海默病功能状态的远程测量技术（RMTs）。该联盟与欧洲药品管理局（EMA）合作，以获取关于确定有意义的功能领域、选择RMTs以及临床研究设计方面的反馈，以评估在阿尔茨海默病临床研究中使用RMTs的可行性。我们总结了这些反馈及经验教训，以指导未来的项目。