Wehling Martin
Clinical Pharmacology Mannheim, University of Heidelberg, Mannheim, Germany.
J Transl Med. 2008 Jun 17;6:31. doi: 10.1186/1479-5876-6-31.
"Translational medicine" as a fashionable term is being increasingly used to describe the wish of biomedical researchers to ultimately help patients. Despite increased efforts and investments into R&D, the output of novel medicines has been declining dramatically over the past years. Improvement of translation is thought to become a remedy as one of the reasons for this widening gap between input and output is the difficult transition between preclinical ("basic") and clinical stages in the R&D process. Animal experiments, test tube analyses and early human trials do simply not reflect the patient situation well enough to reliably predict efficacy and safety of a novel compound or device. This goal, however, can only be achieved if the translational processes are scientifically backed up by robust methods some of which still need to be developed. This mainly relates to biomarker development and predictivity assessment, biostatistical methods, smart and accelerated early human study designs and decision algorithms among other features. It is therefore claimed that a new science needs to be developed called 'translational science in medicine'.
“转化医学”作为一个时髦的术语，正越来越多地被用于描述生物医学研究人员最终帮助患者的愿望。尽管在研发方面加大了努力和投入，但在过去几年里，新型药物的产出却在急剧下降。人们认为改善转化过程是一种补救办法，因为研发过程中临床前（“基础”）阶段和临床阶段之间难以过渡，是导致投入与产出差距不断扩大的原因之一。动物实验、试管分析和早期人体试验根本无法充分反映患者的情况，从而可靠地预测新型化合物或设备的疗效和安全性。然而，只有在转化过程得到强有力方法的科学支持时，这一目标才能实现，其中一些方法仍有待开发。这主要涉及生物标志物的开发和预测性评估、生物统计学方法、智能且加速的早期人体研究设计以及决策算法等。因此，有人主张需要发展一门名为“医学转化科学”的新学科。
