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 ziad.taib@astrazeneca.com.
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 (khelga@chalmers.se) and Mahdi Hashemi (mahdi.hashemi@astrazeneca.com)
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 |
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.
Learning MATLAB, Tobin A. Driscoll ISBN:
978-0-898716-83-2 (The book is published by SIAM).
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.
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.
You can consult some old
exams here: Exam08, Exam10 with solutions,
Exam11 with solutions,
Exam14, Exam16