Statistical Considerations on Subgroup Analysis in Clinical Trials

Abstract

Mohamed Alosh, Kathleen Fritsch, Mohammad Huque, Kooros Mahjoob, Gene Pennello, Mark Rothmann, Estelle Russek-Cohen, Fraser Smith, Stephen Wilson & Lilly YueMohamed Alosh (E-mail: ), Kathleen Fritsch (E-mail: ), Stephen Wilson (E-mail: ), Division of Biometrics III, OB, OTS, CDER; Mohammad Huque (E-mail: ), Office of Biostatistics, OTS, CDER; Fraser Smith (E-mail: ), Division of Biometrics IV, OB, OTS, CDER; Kooros Mahjoob (E-mail: ), Division of Biometrics I, OB, OTS, CDER; Gene Pennello (E-mail: ), Lilly Yue (E-mail: ), Division of Biostatistics, OSB, CDRH; Mark Rothmann (E-mail: ), Division of Biometrics II, OB, OTS, CDER; Estelle Russek-Cohen (E-mail: ), Division of Biostatistcs, OBE, CDER, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993.