- Docente: Giulia Zardi
- Credits: 3
- Language: English
- Teaching Mode: Traditional lectures
- Campus: Bologna
- Corso: First cycle degree programme (L) in Statistical Sciences (cod. 8873)
Learning outcomes
By the end of this course the student will acquire knowledge in key statistical components required when conducting a randomized clinical trial (RCT), especially in accordance to ICH E9 guideline. Particularly the student will be able to: - get familiar with randomization and blinding concepts; - undertand different types of trial designs; - understand which aspects to take into consideration while designing a trial, defining a primary outcome, performing sample size calculation, and analyzing trial data; - define analysis populations appropriately in order to address specific research questions; - work with different types of outcomes and select statistical techniques accordingly.
Course contents
- Historical Aspects of Clinical Research
- Ethical Considerations
- Clinical Trial Designs
- Bias and Random Error
- Randomization and Blinding
- Study Protocol
- Objectives and Endpoints
- Analysis Population
- Sample Size Calculation
- Data Analysis
Readings/Bibliography
Handouts provided by the teacher.
Suggested readings may be:
- Friedman, Furberg & DeMets (5th edition, 2015), Fundamentals of Clinical Trials, Springer
- Pocock (1986), Clinical Trials - A Practical Approach, Wiley and Sons
- Glasser (2008), Essentials of Clinical Research, Springer
Teaching methods
- Lectures
- Demonstration of practical statistical analysis through computer laboratory sessions (using SAS).
Assessment methods
Students will be evaluated on:
- Understanding Quizzes/Homework Assignments
- Laboratory Exam (groups of max. 4 students)
- Oral Test
Teaching tools
- Slides
- Laboratory tutorials
Office hours
See the website of Giulia Zardi