Abstract
"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'.
Highlights
These days, "translational medicine" is a fashionable term describing the inclination of biomedical researchers to help patients
Public and private responses in reflection of this observation have been numerous during the past years
This includes the "Critical Path" initiative by the FDA [2], the re-orientation of the NIH ("road-map"), enforced by Dr Zerhouni's leadership towards translational medicine with an estimated 10 billion USD channeled into translational medicine centers and other activities; major drug companies and US universities (e.g. Duke or UPenn) are being driven to establish translational medicine departments or at least working groups
Summary
These days, "translational medicine" is a fashionable term describing the inclination of biomedical researchers to help patients.As if this wish would be novel, it is being increasingly used by scientific funding agencies (e.g. NIH, European Union framework programs), regulatory authorities (e.g. FDA), researchers and patient care providers.This inflationary use has been triggered by a simple and powerful fact: despite increased efforts and investments into R&D, the output of novel medicines has been declining dramatically over the past years [1]. Test tube analyses and early human trials do not reflect the patient situation well enough to reliably predict efficacy and safety of a novel compound or device.
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