C Micael Gibson, MS, MD.pptVIP

C. Michael Gibson, M.S., M.D. Harvard Medical School State of the Art in the Adjudication of Cardiovascular Endpoints 冤嗓解沂囚位地刃母吞荚彻蛰缉厨拥幼汀好拼同朱翼若胳悠巡履茁粹块具C Michael Gibson, MS, MDC Michael Gibson, MS, MD Goal of Universal Definitions In the conduct of non-inferiority trials, definitions with increased specificity minimize bias towards showing non-inferiority The increased specificity of the new definitions requires careful design of eCRFs and careful collection of source documents so sufficient information is available to permit adjudication If source documents are not collected to adjudicate events, “true positive” events may not be adjudicated as such leading to lower event rates, and reduced power to demonstrate non-inferiority (or superiority as well) 罢吭沿巩艘统羌楷扒踊蔽裤疵磅候宣谓芯括臂歧叹潞香座数莹裳粪廖抢宇C Michael Gibson, MS, MDC Michael Gibson, MS, MD FDA Standardized Definitions for CV Outcomes Trials July 2009 Initial Draft definitions issued Nov 2009 – Feb 2010 variety of working group meetings to discuss definitions March 2010 Revised draft definitions issued Targeted completion of draft definitions late 2Q2010 - definitions will be posted for 30 days for public comment Ultimate goal is a white paper (late 2010?) CRF standardization possibly to complete mid-2011 Stakeholders: FDA, CDER, CPI, ACC, ACROs, CROs, CDISC, CTTI, HL7, NHLBI, PhRMA, pharmaceutical industry Working group representatives: Cleveland Clinic, Columbia, Duke Cardiovascular Research Institute, HCRI, TIMI, Brigham Women’s, St. Louis University, PERFUSE/Beth Israel, FDA neurology working group 涕粱莽塌竟碳夕吼平怨奉测驶垫烧狈殷轻蜒个讳溶纠同雷约儡婶替却怔检C Michael Gibson, MS, MDC Michael Gibson, MS, MD Where Can You Find The New Definitions? /index.php/Clinical_event_adjudication Dr. Gibson is Founder and Editor-in-Chief of WikiDoc, the world’s largest on line medical encyclopedia () Non-profit foundation, no pharma or device support Over 71,000 chapters, 1,800 contributors, about 500,000 revisions 雇刘轮唉场滞甘嚼脾鸡舒讯广转浴拙理吏语蜀邱盖拾斯篮树筛段傻淑酋胆C Michae