INTRODUCTION TO CLINICAL TRIALS I

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 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.

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 641

Statistical issues in the design of clinical trials, basic survival analysis, data collection and sequential monitoring.

BMI 544

Practical training and skills required in clinical and healthcare research; design, implementation, and conduct of clinical trials and health services research studies; protocol and informed consent development using protocol templates; regulatory requirements; human subjects research protections considerations; data and safety monitoring plans; data collection strategies and data management; strategies to recruit/retain diverse and equitable study participants; research study agreements; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for participant safety and study success; preparation of investigator-INDs/IDEs; and investigator responsibilities.