79303 - Lab 2

Course Unit Page

  • Teacher Giulia Zardi

  • Credits 3

  • Teaching Mode Traditional lectures

  • Language English

Academic Year 2019/2020

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; - understand 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