Statistical Thinking for Clinical Trials (STCT)

Module Title: Statistical Thinking for Clinical Trials

Module No.:


Semester / Term:



1 Semester

Module Type(s):


Regularly offered in:


Workload: 150 h

Credit Points: 5

Admission Requirements:


Language of Instruction:


Contributing Courses to Module:


Lectures: 30 h
Self-study: 90h
Self-testing: 30 h

Course Coordinator(s) / Tutor(s):

Module Director:

PD. Dr. Werner Wierich

References to Other Programs:

• N/A

References to Other Modules in the Program:

• Medical Writing
• Conducting Clinical Trials
• Clinical Data Management

Qualification and Educational Objectives of the Module:

This course is designed to provide an insight into key bio-statistical aspects of clinical trials relevant for non-statistical professionals within clinical research.

Course Content of the Module:

• Statistical aspects of trial design
• ICH requirements for statistical analyses
• Basic statistical concepts: Estimation, confidence intervals, testing, p-values, t-tests, and type I and type II errors
• Intent-to-treat and analysis sets
• Multicenter trials and analysis of variance
• Correlation, regression, and analysis of covariance
• Analysis of binary, categorical, and ordinal data
• Power, sample size, statistical significance, and clinical relevance
• Practical issues in multiple testing
• Assessing equivalence or non-inferiority
• Meta-analysis
• Methods of survival data analysis

Teaching Methods:

See the contributing course outline(s)


See the contributing course outline(s)

Percentage of the Module Grade Relative to the Final Grade for the Program:


Prerequisites to Qualify for Assessment:


See course outline(s)

Exam, 90 minutes (100%)