題目:Active Surveillance System for Clinical Effectiveness and Safety
主講人：林峰祺 博士
摘要:Although the randomized control trial is considered as a gold standard research approach for the new drug approval, such a trial may fail to detect all the adverse drug events. Numerous drugs were still withdrawn after the market approval because of the unexpected severe adverse drug reaction. Therefore, it is a critical issue to establish a well-design effective and convenient active post-marketing drug surveillance system, which is the process of continuous monitoring and evaluation of the drug safety and effectiveness after their listing. We implemented a web-based clinical surveillance system, the National Taiwan University Hospital Clinical Surveillance System (NCSS) that can integrate the workflow of cohort identification to accelerate the survey process of disease and medication prescription patterns and provide a high re-usability infrastructure for a computerized workflow to capture relevant longitudinal clinical data and make those data repositories reusable. We demonstrated the practical example of investigating the difference of effectiveness and safety between NOACs and warfarin in the patients with non-valvular atrial fibrillation at NCSS. We efficiently identified 2,357 non-valvular AF patients with newly prescribed oral anticoagulant between 2010 and 2015 and further developed one main cohort and two sub-cohorts for measuring ischemic stroke as clinical effectiveness outcome and intracranial hemorrhage as safety outcome separately. In ischemic stroke, compared to warfarin users, NOACs users have a significantly lower risk of ischemic stroke after adjusting for age, sex, comorbidity and co-medication in intention-to-treat (ITT) analysis (P = 0.01) but have a comparable risk in as-treated (AT) analysis (P = 0.12) after the 2-year follow-up. In intracranial hemorrhage, NOACs users have a comparable risk of ICH both in ITT (P = 0.68) and AT analysis (P = 0.15).The NCSS systems can integrate the workflow of cohort identification to accelerate the survey process of clinically relevant problems and provide decision support in the daily practice of clinical physicians, thereby making the benefit of evidence-based medicine a reality.
時間：108年09月20日(星期一13：30 - 13:50)
地點：臺北大學三峽校區電機資訊學院 電101教室
