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Home / News & Events / MCPMod: A Library for the Design and Analysis of Dose Finding Trials

MCPMod: A Library for the Design and Analysis of Dose Finding Trials

Presented: September 13th, 2007

Speaker: José Pinheiro, Novartis

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Poor understanding of dose response at the end of Phase II of a clinical drug development program often leads to incorrect dose selection for the confirmatory phase. In fact, this has been identified as one of the leading causes of the high attrition rates in late development, currently observed in the pharmaceutical industry. Novel dose finding designs and methods have been developed recently with the goal of increasing the efficiency and accuracy of Phase II trials. MCP-Mod is one of such methods, which combines aspects of multiple comparison procedures (MCP) with modeling. We will provide an overview of an S-PLUS library implementing the MCP-Mod methodology, using real trial data to illustrate its design and analysis capabilities.

Presenter Information

Jose Pinheiro
José Pinheiro, Novartis

José Pinheiro received his Ph.D. in Statistics from the University of Wisconsin -- Madison in 1994. Afterwards, he worked for two years in the Department of Biostatistics at the same university in the design and analysis of clinical trials, and in research in Group Sequential Designs. In 1996 he joined the Statistics Research department at Bell Labs, as a Member of Technical Staff. José moved to Novartis Pharmaceuticals in 2001, joining the Methodology group in Biostatistics, currently heading the U.S. group. He has been involved in methodological development in various areas of drug development, including dose-finding, randomization schemes, and longitudinal data analysis. For his contributions to the company, he  received a Novartis Leading Scientist Award in 2006.

José is co-leader of the PhRMA working group on Adaptive Dose-Ranging Designs and a member of the PhRMA WG on Adaptive Designs. He is a member of the PhRMA Biostatistics and Data Management Technical Group, and the secretary of  ENAR. José is a co-developer, with Prof. Douglas Bates, of the NLME software in S-PLUS and R for fitting and analyzing linear and non-linear mixed-effects models. They have also co-authored the book "Mixed-Effects Models in S and S-PLUS", a standard reference in the area.