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Artificial Intelligence and Machine Learning in Clinical Medicine, 2023
This first article in a series describes the history of artificial intelligence in medicine; the use of AI in image analysis, identification of disease outbreaks, and diagnosis; and the use of chatbots.
Journal Article
Artificial Intelligence in Medicine
The editors announce both a series of articles focusing on AI and machine learning in health care and the 2024 launch of a new journal,
NEJM AI
, a forum for evidence, resource sharing, and discussion of the possibilities and limitations of medical AI.
Journal Article
Real-World Evidence — Where Are We Now?
Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
Journal Article
The Current and Future State of AI Interpretation of Medical Images
Using AI to Interpret Medical ImagesThe authors examine the advantages and limitations of current clinical radiologic AI systems, new clinical workflows, and the potential effect of generative AI and large multimodal foundation models.
Journal Article
An Evidence-Based Approach to Covid-19 Vaccination
An Evidence-Based Approach to Covid-19 VaccinationThis article from the FDA compares broad U.S. recommendations on Covid vaccination with those from other countries and announces the adoption of an evidence-based approach to such recommendations.
Journal Article
The Drug-Dosing Conundrum in Oncology — When Less Is More
Doses and schedules of oncology drugs are sometimes inadequately characterized before registration trials. The “more is better” paradigm is still used for dose selection, despite the recognition that targeted therapies require alternative approaches to dose optimization.
Journal Article
Secondary Cancers after Chimeric Antigen Receptor T-Cell Therapy
Secondary Cancers after CAR-T TherapyAs of December 31, 2023, the FDA had become aware of 22 cases of T-cell cancers that occurred after treatment with CAR-T products. For now, such cancers appear to be relatively rare adverse events.
Journal Article
A Covid-19 Milestone Attained — A Correlate of Protection for Vaccines
The rapid identification of a correlate of protection for Covid-19 vaccines — on the basis of several harmonized randomized phase 3 trials using common validated assays — constitutes an important success in vaccinology.
Journal Article
Controversy and Progress in Alzheimer’s Disease — FDA Approval of Aducanumab
The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic has been rocky and contentious. The hope is that despite its limitations, this first-in-class drug will open the door to more efficacious therapies.
Journal Article
Prevention of Central Line–Associated Bloodstream Infections
Central Line–Associated Bloodstream InfectionsThe author reviews the patient, provider, and device factors that contribute to central line–associated bloodstream infections and discusses preventive strategies.
Journal Article