The 2+1 paradigm:an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials

作     者：Harris A.Ahmad Klaus Gottlieb Fez Hussain 

作者机构：Rheumatology and GastroenterologyBioClinica Inc.PrincetonNJUSA Immunology and Internal MedicineQuintiles Inc.Research Triangle ParkNCUSA 

出 版 物：《Gastroenterology Report》 (胃肠病学报道（英文）)

年 卷 期：2016年第4卷第1期

页      面：35-38,I0002页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

主　　题：ulcerative colitis endoscopy clinical trials 

摘      要：Despite its importance and potential impact in clinical trials,central reading continues to be an under-represented topic in the literature about inflammatory bowel disease(IBD)clinical *** several IBD studies have incorporated central reading to date,none have fully detailed the specific methodology with which the reads were *** we outline key principles for designing an efficient central reading paradigm for an ulcerative colitis(UC)study that addresses regulatory,operational and clinical *** a step towards standardization of read methodology for the growing number of multicenter phase 3 clinical trials in IBD,we have applied these principles to the design of an optimal read methodology that we call the‘2þ1 paradigm.’The 2þ1 paradigm involves the use of both site and central readers,validated scoring criteria and multiple measures for blinding readers,all of which contribute to reducing bias and generating a reliable endoscopic subscore that reflects endoscopic disease *** paradigm can be utilized while maintaining a practical workflow compatible with an operationally feasible clinical *** 2þ1 paradigm represents a logical approach to endoscopic assessment in IBD clinical trials,one that should be considered attractive to prospective sponsors,contract research organizations,key opinion leaders and regulatory authorities and be ready for implementation and further evaluation.