Learning transport processes with machine intelligence.
Ontology highlight
ABSTRACT:
SUBMITTER: Miniati F
PROVIDER: S-EPMC9271097 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe increasing availability of healthcare data and rapid development of big data analytic methods has opened new avenues for use of Artificial Intelligence (AI)- and Machine Learning (ML)-based technology in medical practice. However, applications at the point of care are still scarce.ObjectiveReview and discuss case studies to understand current capabilities for applying AI/ML in the healthcare setting, and regulatory requirements in the US, Europe and China.MethodsA targeted narrative literature review of AI/ML based digital tools was performed. Scientific publications (identified in PubMed) and grey literature (identified on the websites of regulatory agencies) were reviewed and analyzed.ResultsFrom the regulatory perspective, AI/ML-based solutions can be considered medical devices (i.e., Software as Medical Device, SaMD). A case series of SaMD is presented. First, tools for monitoring and remote management of chronic diseases are presented. Second, imaging applications for diagnostic support are discussed. Finally, clinical decision support tools to facilitate the choice of treatment and precision dosing are reviewed. While tested and validated algorithms for precision dosing exist, their implementation at the point of care is limited, and their regulatory and commercialization pathway is not clear. Regulatory requirements depend on the level of risk associated with the use of the device in medical practice, and can be classified into administrative (manufacturing and quality control), software-related (design, specification, hazard analysis, architecture, traceability, software risk analysis, cybersecurity, etc.), clinical evidence (including patient perspectives in some cases), non-clinical evidence (dosing validation and biocompatibility/toxicology) and other, such as e.g. benefit-to-risk determination, risk assessment and mitigation. There generally is an alignment between the US and Europe. China additionally requires that the clinical evidence is applicable to the Chinese population and recommends that a third-party central laboratory evaluates the clinical trial results.ConclusionsThe number of promising AI/ML-based technologies is increasing, but few have been implemented widely at the point of care. The need for external validation, implementation logistics, and data exchange and privacy remain the main obstacles.
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Project description:IntroductionArtificial intelligence based on machine learning has made large advancements in many fields of science and medicine but its impact on pharmacovigilance is yet unclear.ObjectiveThe present study conducted a scoping review of the use of artificial intelligence based on machine learning to understand how it is used for pharmacovigilance tasks, characterize differences with other fields, and identify opportunities to improve pharmacovigilance through the use of machine learning.DesignThe PubMed, Embase, Web of Science, and IEEE Xplore databases were searched to identify articles pertaining to the use of machine learning in pharmacovigilance published from the year 2000 to September 2021. After manual screening of 7744 abstracts, a total of 393 papers met the inclusion criteria for further analysis. Extraction of key data on study design, data sources, sample size, and machine learning methodology was performed. Studies with the characteristics of good machine learning practice were defined and manual review focused on identifying studies that fulfilled these criteria and results that showed promise.ResultsThe majority of studies (53%) were focused on detecting safety signals using traditional statistical methods. Of the studies that used more recent machine learning methods, 61% used off-the-shelf techniques with minor modifications. Temporal analysis revealed that newer methods such as deep learning have shown increased use in recent years. We found only 42 studies (10%) that reflect current best practices and trends in machine learning. In the subset of 154 papers that focused on data intake and ingestion, 30 (19%) were found to incorporate the same best practices.ConclusionAdvances from artificial intelligence have yet to fully penetrate pharmacovigilance, although recent studies show signs that this may be changing.
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