Austin Health

Title
Can preclinical drug development help to predict adverse events in clinical trials?
Publication Date
2022-01
Author(s)
Chi, Lap Hing
Burrows, Allan D
Anderson, Robin L
Subject
Adverse events
Clinical trials
Drug development
Novel technologies
Preclinical safety testing
Type of document
Journal Article
OrcId
0000-0003-0983-3474
0000-0003-0595-1414
0000-0002-6841-7422
DOI
10.1016/j.drudis.2021.08.010
Abstract
The development of novel therapeutics is associated with high rates of attrition, with unexpected adverse events being a major cause of failure. Serious adverse events have led to organ failure, cancer development and deaths that were not expected outcomes in clinical trials. These life-threatening events were not identified during therapeutic development due to the lack of preclinical safety tests that faithfully represented human physiology. We highlight the successful application of several novel technologies, including high-throughput screening, organs-on-chips, microbiome-containing drug-testing platforms and humanised mouse models, for mechanistic studies and prediction of toxicity. We propose the incorporation of similar preclinical tests into future drug development to reduce the likelihood of hazardous therapeutics entering later-stage clinical trials.
Link
Citation
Drug discovery today 2022; 27(1): 257-268
Jornal Title
Drug discovery today

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