STATISTICAL METHODS FOR CLINICAL TRIALS

BMI/POPHLTH 551

Designed for population health researcher. Topics include descriptive statistics, elementary probability, probability distributions, one- and two-sample normal inference (point estimation, hypothesis testing, confidence intervals), power and sample size calculations, one- and two-sample binomial inference, underlying assumptions and diagnostic work.

BMI/STAT 542

Intended for biomedical researchers interested in the design and analysis of clinical trials. Topics include definition of hypotheses, measures of effectiveness, sample size, randomization, data collection and monitoring, and issues in statistical analysis.

BMI/STAT 541

Course designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications used for each topic.

BMI/STAT 642

Methods for analysis of case-control, cross sectional, and cohort studies. Covers epidemiologic study design, measures of association, rates, classical contingency table methods, and logistic and Poisson regression.

BMI/STAT 643

Gain an understanding of fundamental elements of clinical trials (such as objectives, endpoints, surrogate endpoints, and statistical decisions) and statistical design considerations (such as randomization and blinding). Designs of clinical trials for Phase I, II, and III studies including single-arm, two-arm, and drug combination trials. Introduction to adaptive designs for precision medicine and master protocol designs such as umbrella trials and basket trials.