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Luyan Dai1, Shuran Yao2* and Robert Makuch3* 1Director, Regional Head of Statistics Asia, Biostatistics and Data Sciences Asia, Boehringer Ingelheim, Germany 2Graduate Student, Regulatory Affairs Program, Yale University, USA 3Professor of Biostatistics and Director of Regulatory Affairs Program, Yale University, USA *Corresponding Author: Shuran Yao, 60 College Street, LEPH 203, New Haven CT USA 06520, E-mail: shuran.yao@yale.edu Robert Makuch, 60 College Street, LEPH 203, New Haven, CT USA 06520, Tel: 203-785-2842; Fax: 203-785-6912; E-mail: robert.makuch@yale.edu

Independent Data Monitoring Committees and Heterogeneity in MRCTs: Issues and Recommendations