Biostatistics for Clinical Trials

General

Prefix

ACR

Course Number

624

Course Level

Graduate

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: