Below you find the program of the course: lectures, exercise sessions and computer labs. Some additional information can be found in the plan of the course.

Learning Objectives

After having completed this course the student is supposed to be able to handle the design and the analysis of the most common types of clinical trials including blinding, randomization and sample size calculation. Moreover, the student is supposed to master the most usual statistical techniques for analyzing such trials. Some personal thoughts about the role of the statistician in the pharmaceutical industry can be found here.

Teachers

Course coordinator: Ziad Taib (ziad@chalmers.se)

Teachers: José Sanchez (jose.sanchez1 @astrazeneca.com and Ziad Taib

Lab Supervisors: Helga Ólafsdóttir (khelga@chalmers.se), Mahdi Hashemi (mahdi.hashemi@astrazeneca.com) 

Course contents

During the course, there will be 13 lectures during which the following topics will be covered

1. Introduction to clinical trials
2. Basic statistical methods for clinical trials
3. Basic Designs and Randomization
4. Designs for Clinical Trials
5. Classification of Clinical Trials
6. Continuous Data
7. Non-continuous Data
8. Safety Data
9. Survival Analysis
10. Sample size determination
11. Multiplicity
12. Statistical programming and flow of data

Course details

Chapters 1-12 in the book plus the material in the handouts. For Chapters 1-7, reading instructions are included in the lecture notes. For the technical chapters, you should learn the content of the following chapters Chapter 8: 8.1-8.5, Chapter 9: 9.1-9.6, Chapter 10: 10.1-10.4 and 10.6, Chapter 11: 11.1-11.4 (until example 11.4.1) and 11.5-11.7 (until example 11.7.2), Chapter 12: 12.6 as well as the lectures notes distributed as handouts. Reading instructions can be found here.

Examination:

Open book written exam and compulsory computer project. The written exam is worth 30 scores (pass (G) = 15 scores, excellent (VG) = 24 scores).  Any material is allowed at the exam . However, the exam needs still to be done individually. More information about the examination can be found here. Old exams will be made available online. You can consult some possible questions old exams here: Exam08, Exam10 with solutions, Exam11 with solutions, Exam14, Exam16

Program

The schedule of the course is in TimeEdit.

Lectures

Schedule: lectures

 

WED 22/1	Lecture	José Sanchez	10:00 - 11:45	Introduction to Clinical Trials
FRI 24/1	Lecture	José Sanchez	10:00 - 11:45	Basic Statistical Concepts
WED 29/1	Lecture	Ziad Taib	10:00 - 11:45	Basic Designs and Randomization
FRI 31/1	Lecture	Ziad Taib	10:00 - 11:45	Designs for Clinical Trials
FRI 7/2	Lecture	Ziad Taib	10:00 - 11:45	Classification of Clinical Trials
WED 12/2	Lecture	Ziad Taib	10:00 - 11:45	Continuous Data
FRI 14/2	Lecture	Ziad Taib	10:00 - 11:45	Categorical Data
WED 19/2	Lecture	José Sanchez	10:00 - 11:45	Issues in Safety
FRI 21/2	Lecture	José Sanchez	10:00 – 11:45	Survival Analysis
WED 26/2	Lecture	José Sanchez	10:00 - 11:45	Sample size determination
FRI 28/2	Lecture	Ziad Taib	10:00 - 11:45	More on Sample size determination - Multiplicity
WED 4/3	Lecture	Ziad Taib	10:00 - 11:45	Gatekeeping
FRI 6/3	Lecture	Ziad Taib	10:00 - 11:45	Data flow/ Repetition/Exam

 

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Computer labs
Each student or group of students defines a research question, plans an experiment, writes a protocol, carries out the experiment, analyses the data, draws conclusions and reports the work. Lab sessions will primarily be used for discussions about the projects, to stimulate reflection on issues related to clinical trial design, conduct and interpretation. A portion of the time will be available for project work. However, the essential part of the work should be carried out between the laboratory sessions.
More information on the computer labs can  be made found below.

Schedule: Computer lab

WED 29/1	Group building and  Project choice	Helga Ólafsdóttir	13:00 - 15:00
WED 12/2	Handing in first version of Study Protocol	Helga Ólafsdóttir	13:00 - 15:00
WED 19/2	Expect data and Study Protocol back with request for correction	Helga Ólafsdóttir	13:00 - 15:00
WED 26/2	Corrected Study Protocol handed back and work on analysis	Helga Ólafsdóttir	13:00 - 15:00
WED 4/3	Analysis and Reporting	Helga Ólafsdóttir	13:00 - 15:00
Wed 11/3	Report	Helga Ólafsdóttir

A description of the computer lab can be found here and more useful information in the following documents: T2DM Guidelines, COPD Guidelines, Sample size 1, Sample size 2, Sample size 3, Protocol, Protocol. An example of old data can be found here.

Recommended exercise

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Reference literature:

“Design and Analysis of Clinical Trials: Concepts and Methodologies, Wiley Series in Probability and Statistics by Shein-Chung Chow, Jen-Pei Liu” and the material handed out at the lectures

 

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