Regulatory Considerations on the use of Machine Learning based tools in Clinical Trials

被引：0
|
作者：
Maurizio Massella
Diego Alejandro Dri
Donatella Gramaglia
机构：
[1] Italian Medicines Agency (AIFA),Clinical Trials Office
[2] Sapienza University of Rome,Department of Drug Chemistry and Technology
来源：
Health and Technology | 2022年 / 12卷
关键词：
Artificial intelligence; Big data; Clinical trials; Digital health; Machine learning; Regulatory;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：1085 / 1096
页数：11
相关论文
共 50 条
  • [41] Increasing the Efficiency of ALS Clinical Trials Using Machine Learning
    Ennist, David
    Taylor, Albert
    Beaulieu, Danielle
    Cuerdo, Jonavelle
    Conklin, Andrew
    Keymer, Mike
    NEUROLOGY, 2019, 92 (15)
  • [42] Machine learning prediction of side effects for drugs in clinical trials
    Galeano, Diego
    Paccanaro, Alberto
    CELL REPORTS METHODS, 2022, 2 (12):
  • [43] Application of machine learning methods in clinical trials for precision medicine
    Wang, Yizhuo
    Carter, Bing Z.
    Li, Ziyi
    Huang, Xuelin
    JAMIA OPEN, 2022, 5 (01)
  • [44] Machine Learning for Clinical Trials in the Era of COVID-19
    Zame, William R.
    Bica, Ioana
    Shen, Cong
    Curth, Alicia
    Lee, Hyun-Suk
    Bailey, Stuart
    Weatherall, James
    Wright, David
    Bretz, Frank
    van der Schaar, Mihaela
    STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2020, 12 (04): : 506 - 517
  • [45] In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study
    Badano, Aldo
    Badal, Andreu
    Glick, Stephen
    Graff, Christian G.
    Samuelson, Frank
    Sharma, Diksha
    Zeng, Rongping
    MEDICAL IMAGING 2017: PHYSICS OF MEDICAL IMAGING, 2017, 10132
  • [46] Implementing pharmacogenetics in clinical trials: considerations about current methodological, ethical, and regulatory challenges
    Garcia-Garcia, Irene
    Seco-Meseguer, Enrique
    Borobia, Alberto M.
    Carcas-Sansuan, Antonio J.
    EXPERT REVIEW OF CLINICAL PHARMACOLOGY, 2024, 17 (01) : 1 - 10
  • [47] MONOCLONAL AND ENGINEERED ANTIBODIES FOR HUMAN PARENTERAL CLINICAL USE - REGULATORY CONSIDERATIONS
    MANOHAR, V
    HOFFMAN, T
    TRENDS IN BIOTECHNOLOGY, 1992, 10 (09) : 305 - 309
  • [48] Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer
    Taieb, Julien
    Aranda, Enrique
    Raouf, Sherif
    Dunn, Helen
    Arnold, Dirk
    CLINICAL COLORECTAL CANCER, 2021, 20 (01) : 42 - +
  • [49] Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy
    Roberts, Jeffrey N.
    Gruber, Marion F.
    VACCINE, 2015, 33 (08) : 966 - 972
  • [50] The Use of Personal Digital Assistants as Tools for Work-Based Learning in Clinical Internships
    Akkerman, Sanne
    Filius, Renee
    JOURNAL OF RESEARCH ON TECHNOLOGY IN EDUCATION, 2011, 43 (04) : 325 - 341
12345