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Clinical Informatics & Medical Statistics Research Center

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biosignatures project

BIOSIGNATURES:COMPARATIVE EFFECTIVENESS RESEARCH IN BIOMARKER CLINICAL STUDIES

The concept of utilizing CER to clinical studies has drawn the clinical research society in Taiwan lots of attentions in recent months. A Biosigatures Initiative workshop hosted by Academia Sinica and initiated by Nobel Prize Laureate Prof. Lee Hartwell and Prof. Scott Ramsey, president of International Society for Pharmacoeconomics and Outcomes Research, was taken place in early January, 2011. To improve the outcomes of disease treatment in human beings and to reduce the medical and societal costs in the disease treatments are the main goals of the Biosignatures Initiative. It was estimated that discovery of new biomarkers was increased by 10 folds since 1990. How do these newly discovered biomarkers effectively help in identifying risks in early stage of disease; in providing effective treatments; and in early detection of high risk groups becomes a challenging work. Necessary collaboration among different research teams has to come to an agreement to the treatment management of these severe diseases. The Biosignatures Institute is a collaborative organization among different specialties; it involves the expertise from clinicians, basic scientists, bio and medical informatics, biostatistician and health/pharmaco economists. Disease selected for CER exploration studies in Biosignatures project has to follow certain criteria. The criteria involve whether there are enough clinical expertise and large patient volume with identifiable at-risk population in Taiwan; whether the disease are local relevance, rapid progression that will allow an immediate intervention; whether there are opportunities to improve the outcomes, to possibly change clinical care pathway; whether the biomarkers panel are ready to utilize and conduct the clinical trials to possibly improve the clinical outcomes; whether the clinical information such as database in national level are accessible for economic evaluation. An early detection of oral squamous cell carcinoma (OSCC) CER study has been evaluated and selected as a Biosignatures project using the criteria in Chang Gung University and Chang Gung Memorial Hospital. It is aimed to follow through the validated useful biomarker panels outcome to establish a head-to-head comparison for further cost-effectiveness analysis; and thus eventually to improve the OSCC outcome and reduce the cost simultaneously. In addition, there are other research teams studying biomarkers of different cancers such as hepatocellular cancer, non-small cell lung cancer, lung cancer, and gastric cancer for different clinical purposes in Taiwan. CER can also be adopted to evaluate cost-effectiveness of adopting these biomarker tests in clinical practice.