Biostatistics for Clinical Trials
General
Prefix
ACR
Course Number
624
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
Statistical tools used in the design, monitoring, and analysis of clinical studies. FDA and ICH guidance.
Credits
Min
4
Max
4
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Understand statistical rationale for clinical trials.
Outcome
Interpret clinical trial results using appropriate statistics.
Outcome
Understand some key statistical concepts, including hypothesis testing, p-value, confidence interval, type I error, type II error, statistical power, and sample size.
Outcome
Understand common clinical trial designs, including randomized clinical trials and other common designs in medical device trials.
Outcome
Understand data elements in a clinical trial, including endpoint definition, data and safety monitoring, inclusion and exclusion criteria and how those relate to biostatistics.
Outcome
Understand common statistical analysis strategies and issues in FDA regulated trials.
Outcome
Understand the idea of some more advanced statistical methodology applied in clinical trials, such as non-inferiority, adaptive design, Bayesian methods, meta-analysis and other topics.
Outcome
(RAS) Describe the principles of experimental design, sample size estimation, and statistical analysis methods to use in clinical trial protocols, using mathematical and computational thinking.
Dependencies
Courses
ACR624
is a
prerequisite
for:
Programs
ACR624
is a
completion requirement
for: