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Reproducibility, relevance and reliability as barriers to efficient and credible biomedical technology translation
Advanced Drug Delivery Reviews ( IF 16.1 ) Pub Date : 2022-01-20 , DOI: 10.1016/j.addr.2022.114118
Ulrich Dirnagl 1 , Georg N Duda 2 , David W Grainger 3 , Petra Reinke 4 , Ronenn Roubenoff 5
Affiliation  

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 Few solid conclusions from clinical studies are replicable and many remain unpublished.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.



中文翻译:

可重复性、相关性和可靠性是有效和可信的生物医学技术转化的障碍

生物医学研究的准确性和与改善医疗保健的相关性越来越被认为是代价高昂的问题。基础研究数据质量、报告和方法以及可重复性是涉及这一挑战的常见因素。主要在啮齿动物中进行的疾病和治疗的临床前模型在复制大多数人类条件方面存在已知缺陷。几十年来,人们承认它们对人类结果的翻译很差。临床数据质量和数量也被认为是不足的;金标准随机临床试验费用昂贵。临床研究中很少有可靠的结论是可复制的,而且许多尚未发表。因此,从基础生物医学研究到交付给临床从业者的创新解决方案的转化途径效率极低且成本高昂,因为资源浪费、人类从未见过的基础发现的早期主张以及临床上可用于无数疾病的新的改进解决方案很少。改进这一生物医学研究战略并为可靠性、转化相关性、可重复性和临床影响提供资源,需要在资助和同行评审层面进行仔细分析和一致执行。

更新日期:2022-01-31
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