Course Outline: MAS367, Clinical Trials
Below is an outline of the
topics covered in the course, together with references to the course text. Clicking on the links in each topic will
provide a brief summary of each of the items in that topic. Return to
MAS367 main page
|
No. |
Topic |
Contents |
References to course text |
|
1 |
i)
Definition
of a trial ii)
Historical
background iii)
Empirical
approach and importance of statistics iv)
Ethical
issues |
i)
1.1. ii)
1.2.1 iii)
1.2.2 iv)
1.2.3 |
|
|
2 |
i)
General
structure ii)
Eligible
patients iii)
Control
groups iv)
Allocation
at random |
i)
1.3 ii)
1.3.1 iii)
1.3.2 iv)
1.3.3 |
|
|
3 |
i)
What
is bias ii)
Selection
bias iii)
Allocation
bias iv)
Assessment
bias v)
Publication
bias and stopping rules |
i)
2.1 ii)
2.2.1 iii)
2.2.2 iv)
2.2.3 v)
2.2.4
& 2.2.5 |
|
|
4 |
i)
Why
do it? ii)
Role
of hypothesis tests iii)
Normal
variables iv)
Binary
variables |
i)
3.1 ii)
3.2 iii)
3.3 iv)
3.4 |
|
|
5 |
i)
Simple
randomization ii)
Random
permuted blocks iii)
Unequal
randomization iv)
Stratification v)
Minimization |
i)
4.1 ii)
4.2 iii)
4.3 iv)
4.4 v)
4.5 |
|
|
6 |
i)
Double
and single blindness ii)
Placebos |
i)
5.1 ii)
5.2 |
|
|
7 |
i)
Use
of confidence intervals ii)
Uses
and abuse of baselines iii)
Analysis
of covariance |
i)
6.2 ii)
6.3 iii)
6.4 |
|
|
8 |
i)
The
crossover design ii)
The
model including period effect iii)
Carryover
effect |
i)
10.1/10.2 ii)
10.3 iii)
10.4 |
|
|
9 |
i)
Subgroup
analyses ii)
Methods
for comparing and selecting subgroups iii)
Multiple
outcomes and correction of P-values |
i)
8.1 ii)
8.2/8.3 iii)
8.5 |
|
|
10 |
i)
The
trial protocol ii)
Protocol
deviations iii)
Intention
to treat analysis |
i)
9.1 ii)
9.2 iii)
9.3 |