SESSION I

TITLE:The Treatment of Missing Data in Clinical Trials
SPEAKER: Rod Little, University of Michigan
MODERATOR: Alfred H. Balch

Abstract:

This short course will discuss methods for the statistical analysis of data sets with missing values, focusing particularly on clinical trial data. Topics will include: Definition of missing data; assumptions about mechanisms, including missing at random; pros and cons of simple methods such as complete-case analysis, naïve imputation etc; Weighting methods; multiple imputation and maximum likelihood with missing data; software for handling missing data; missing data in clinical trials, focusing on the National Research Council Study findings and sensitivity analysis for deviations from missing at random.

Prerequisites: Course requires knowledge of standard statistical models such as the multivariate normal, multiple linear regression, contingency tables, as well as matrix algebra, calculus, and basic maximum likelihood for common distributions.

Outline:
Module 1: Introduction and Overview
Module 2: Complete-case analysis, including weighting methods.
Module 3: Maximum Likelihood and Bayesian approaches
Module 4: Imputation, including multiple imputation
Module 5: Missing data in clinical trials

Instructors’ Biography:

Rod Little is Richard D. Remington Distinguished University Professor of Biostatistics at the University of Michigan, where he also holds appointments in the Department of Statistics and the Institute for Social Research. He chaired the Biostatistics Department at Michigan for 11 years. He has over 250 publications, notably on methods for the analysis of data with missing values and model-based survey inference, and the application of statistics to diverse scientific areas, He chaired an influential National Research Council study on the treatment of missing data in clinical trials. Little is an elected member of the International Statistical Institute, a Fellow of the American Statistical Association and the American Academy of Arts and Sciences, and a member of the National Academy of Medicine. In 2005, Little was awarded the American Statistical Association’s Wilks Medal for research contributions, and he gave the President’s Invited Address at the Joint Statistical Meetings. He was the COPSS Fisher Lecturer at the 2012 Joint Statistics Meetings.

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