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Title: Can preclinical drug development help to predict adverse events in clinical trials?
Austin Authors: Hing Chi, Lap;Burrows, Allan D;Anderson, Robin L 
Affiliation: Olivia Newton-John Cancer Research Institute
School of Cancer Medicine, La Trobe University, Bundoora, Victoria, Australia
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia
Issue Date: 29-Aug-2021 2021-08-29
Publication information: Drug Discovery Today 2021; online first: 29 August
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.
DOI: 10.1016/j.drudis.2021.08.010
Journal: Drug Discovery Today
PubMed URL: 34469805
Type: Journal Article
Subjects: adverse events
clinical trials
drug development
novel technologies
preclinical safety testing
Appears in Collections:Journal articles

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