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Reproducibility, relevance and reliability as barriers to efficient and credible biomedical technology translation

Journal

ADVANCED DRUG DELIVERY REVIEWS
Volume 182, Issue -, Pages -

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ELSEVIER
DOI: 10.1016/j.addr.2022.114118

Keywords

Healthcare; Pharmaceutical; Data quality; Preclinical research; Medical device; Predictive; Clinical innovation

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Biomedical research accuracy and relevance are costly problems, with issues in data quality, reporting, methodology, and reproducibility. Preclinical models and clinical data are deficient, leading to inefficient translation from basic research to clinical solutions, resulting in wasted resources and limited new clinical solutions for diseases.
Biomedical research accuracy and relevance for improving healthcare are increasingly identified as costly problems. Basic research data quality, reporting and methodology, and reproducibility are common factors implicated in this challenge. Preclinical models of disease and therapy, largely conducted in rodents, have known deficiencies in replicating most human conditions. Their translation to human results is acknowledged to be poor for decades. Clinical data quality and quantity is also recognized as deficient; gold standard randomized clinical trials are expensive. Few solid conclusions from clinical studies are replicable and many remain unpublished. The translational pathway from fundamental biomedical research through to innovative solutions handed to clinical practitioners is therefore highly inefficient and costly in terms of wasted resources, early claims from fundamental discoveries never witnessed in humans, and few new, improved solutions available clinically for myriad diseases. Improving this biomedical research strategy and resourcing for reliability, translational relevance, reproducibility and clinical impact requires careful analysis and consistent enforcement at both funding and peer review levels. (C) 2022 Elsevier B.V. All rights reserved.

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