Slide 1Using an Independent Statistician to Support a Data Monitoring Committee Patrick D. OMeara, Ph.D. Pat OMeara Associates, Inc. [email protected] FDA/Industry Workshop…
Slide 1Emerging Issues with Adaptation of Clinical Trial Design in Drug Development* H.M. James Hung Division of Biometrics I, Office of Biostatistics, OPaSS, CDER, FDA Presented…
Slide 1Correcting for Selection Bias in Randomized Clinical Trials Vance W. Berger, NCI 9/15/05 FDA/Industry Workshop, DC Slide 2 Outline l l 1. What do we expect of randomization…
Slide 1A Regulatory Perspective on Design and Analysis of Combination Drug Trial* H.M. James Hung Division of Biometrics I, Office of Biostatistics OPaSS, CDER, FDA Presented…
Slide 1FDA/Industry Workshop: Case Studies in M&S Copyright 2006, metrum research group LLC September 29, 2006 1 Exposure-Response (PK-PD) Applied to Model-Based Drug…
Slide 11 Bayesian CTS example @ FDA/Industry Workshop September 18, 2003Copyright Pharsight Case Study in the Use of Bayesian Hierarchical Modeling and Simulation for Design…
Slide 1James Hung, 2004 FDA/Industry Management of Missing Data in Clinical Trials from a Regulatory Perspective H.M. James Hung Div. of Biometrics I, OB/OPaSS/CDER/FDA Presented…
Slide 1FDA/Industry Workshop September, 19, 2003 Johnson & Johnson Pharmaceutical Research and Development L.L.C. 1 Uses and Abuses of (Adaptive) Randomization: An Industry…
Slide 1FDA/Industry Workshop September 14-16, 2005 Critical Path Initiative: What it means for pharmaceutical industry statisticians Walter Offen, Lilly Brenda Gaydos, Lilly…
Slide 1Selection of Differential Expression Genes in Microarray Experiments James J. Chen, Ph.D. Division of Biometry and Risk Assessment National Center for Toxicological…