Current applications and future challenges of machine learning and artificial intelligence in clinical trials: A
Ajsi Kanapari1, Giulia Lorenzoni1, Honoria Ocagli1
1Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Background:
Machine learning (ML) and artificial intelligence (AI) applications have increased across different stages of clinical research. Their use in clinical trials (CTs) has been discussed but not quantified.
Methods:
A scoping review was conducted by searching PubMed, Embase (Ovid), and Scopus for CTs or protocols. The goal was to understand the extent of ML and AI applications in the design, conduct, and analysis of CTs. Screening was performed on Covidence, with GPT model support.
Findings:
After title/abstract and full-text screening, 108 records were included; in some studies, AI/ML was applied across multiple stages. For the design, 20 studies involved advanced methods, six applied them to stratification, four to treatment selection during randomization, six to participant selection, two for outcome assessment, and two for site selection. Seven studies involved them in the collection and analysis of data from wearable devices, and one for monitoring. More commonly, AI/ML has been used at the analysis stage of 93 CTs; however, limitations in reporting trial objectives make it difficult to distinguish the purpose between primary and exploratory analyses.
Interpretation:
This research identifies a serious mismatch between the potential and actual applications of ML in CTs. Considering the potential benefits of ML in CTs, such underuse could hinder the evolution of CTs toward faster and more efficient approaches.
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:29Issues And Trends In Healthcare Delivery System
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
01:11Clinical Trials: Overview
01:12Statistical Software for Data Analysis and Clinical Trials
01:30Current Trends in Nursing II
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...