MSA620, Design and Analysis of Clinical Trials, Spring 2018

Latest news Course continues according to schedule

Welcome to the course! The schedule for the course can be found in TimeEdit. The presentations from the lectures will be published on this page prior to the lecture on the same day. For questions regarding the course email me at

Updates made:

·         26-01-2018: added the two first lectures and included information/document regarding the computer lab.

·         30-01-2018: added lectures 3-4 as well as a new document for the lab

·         31-01-2018: Added some example data set.

·         31-01-2018: Added dates for successive deliveries of the lab

·         06-02-2018: Added a new version of the Designs lecture as well as the Classification and safety lectures

·         09-02-2018 Added lecture notes on continuous and categorical data

·         14-02-2018 Corrected some typos in continuous, added a shortened version of categorical as well as the somewhat updated survival analysis presentation.

·         19-02-2018 Corrected date for third lab session (Wednesday 21-02-2018, 8.00-11.45)

·         01-03-2018 A new version of the sample size calculation slides uploaded. The cancelled lecture needs to be compensated for and the computer lab on 7/3 needs to be changed due to Mahdi and some of the students being unavailable (probably to the 9/3 between 13-15).

·         02-03-2018: lab on 7/3 is now moved to Monday 5/3 between 10-12. Added some exam instructions and some old exams.

·         04-03-2018: Added Multiplicity and Gate keeping presentations

·         09-03-2018: Added presentation on Flow of Data and solutions to exams from 2010 and 2011.


Course coordinator: Ziad Taib

Other teachers: Sofia Tapani and Marita Olsson

Lab supervisors: Helga Ólafsdóttir ( and Mahdi Hashemi (


Course literature

Course material: The book “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. The book can be bought at Cremona.


Course contents

During the course, there will be 12 lectures during which the following topics will be covered

·         Introduction to clinical trials

·         Basic statistical methods for clinical trials

·         Basic Designs and Randomization

·         Designs for Clinical Trials

·         Safety Data

·         Classification of Clinical Trials

·         Cancer Trials

·         Continuous Data

·         Non-continuous Data

·         Longitudinal Data

·         Survival Analysis

·         Multiplicity and Sample size determination


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.


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.


Schedule: lectures


WED 24/1

Sofia Tapani

10:00 - 11:45

Introduction to Clinical Trials

FRI 26/1

Sofia Tapani

10:00 - 11:45

Basic statistical methods

WED 31/1

Ziad Taib

10:00 - 11:45

Basic Designs and Randomization

FRI 2/2

Ziad Taib

10:00 - 11:45

Designs for Clinical Trials

WED 7/2

Ziad Taib

10:00 - 11:45

Classification of Clinical Trials

WED 9/2

Sofia Tapani

10:00 - 11:45

Issues in Safety

FRI 14/2

Ziad Taib

08:00 - 09:45

Continuous Data

FRI 16/2

Ziad Taib

10:00 - 11:45

Categorical Data

FRI 23/3

Marita Olsson

10:00 - 11:45

Survival Analysis

FRI 28/3

Ziad Taib

08:00 - 09:45

 (Cancelled due to illness)

FRI 2/3

Ziad Taib

08:00 - 09:45

Sample size determination

WED 7/3

Ziad Taib

10:00 - 11:45

Multiplicity and Gate Keeping

FRI 9/3

Ziad Taib

10:00 - 11:45

Data issues/ Exam/ Repetition


Computer Lab

Each student or group of students (of max 4) defines a research question, plans an experiment, writes a protocol, generates data, 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. A description of the computer lab can be found here and more useful information in the following documents: T2DM, Guidelines, Sample size, Protocol, Protocol2 and ANCOVA. An example of old data can be found here.



Schedule: Computer lab


WED 31/1

Mahdi Hashemi and Helga Ólafsdóttir

13:00 - 15:00

WED 14/2

Mahdi Hashemi and Helga Ólafsdóttir

13:00 - 15:00

WED 21/2

Mahdi Hashemi and Helga Ólafsdóttir

08:00 - 11:45

WED 5/3

Mahdi Hashemi and Helga Ólafsdóttir

10:00 - 11:45




·         Feb 16: Study protocol

·         Feb 21: Expect data and study protocol back to the students with request for correction

·         Mar 02: Corrected study protocol

·         Mar 16: Report


More information on the computer lab will be added later.

Reference literature:

Learning MATLAB, Tobin A. Driscoll ISBN: 978-0-898716-83-2 (The book is published by SIAM).

Course requirements

The learning goals of the course can be found in the course plan.




Closed book written exam and compulsory computer project. The written exam is worth 30 scores (pass (G) = 15 scores, excellent (VG) = 24 scores). No material is allowed at the exam other than a simple pocket calculator. More information about the examination can be found here. You can find more instructions on the exam here and you can consult some old exams further below.


Examination procedures

In Chalmers Student Portal you can read about when exams are given and what rules apply on exams at Chalmers. In addition to that, there is a schedule when exams are given for courses at University of Gothenburg.

Before the exam, it is important that you sign up for the examination. If you study at Chalmers, you will do this by the Chalmers Student Portal, and if you study at University of Gothenburg, you sign up via GU's Student Portal, where you also can read about what rules apply to examination at University of Gothenburg.

At the exam, you should be able to show valid identification.

After the exam has been graded, you can see your results in Ladok by logging on to your Student portal.

At the annual (regular) examination:
When it is practical, a separate review is arranged. The date of the review will be announced here on the course homepage. Anyone who cannot participate in the review may thereafter retrieve and review their exam at the
Mathematical Sciences Student office. Check that you have the right grades and score. Any complaints about the marking must be submitted in writing at the office, where there is a form to fill out.

At re-examination:
Exams are reviewed and retrieved at the
Mathematical Sciences Student office. Check that you have the right grades and score. Any complaints about the marking must be submitted in writing at the office, where there is a form to fill out.

Old Exam

You can consult some old exams here: Exam08, Exam10 with solutions, Exam11 with solutions, Exam14, Exam16