Clinical Trials (Med Stats A)
MAS367
Credits: 10
Semester: 2
Programme: 24 lectures + 6 tutorials/practicals
Availability: Third and fourth year students. MAS367 alternates
with MAS363. It runs in 1998-99 but not in 1999-00.
Pre-requisites: MAS233 and MAS272 (MAS353 desirable)
Co-requisites: None
Description:
New drugs, new types of operations, new screening programmes are some examples
of new medical procedures whose efficacy needs to be assessed before their
value to patients and to society can be assured. Over the last fifty years
the randomized controlled trial has come to have a dominant role in this
area of medical research. The ideas behind clinical trials are essentially
statistical, and statisticians are closely involved with all aspects of
their design, analysis and implementation. This course introduces the main
statistical ideas, explains why they are needed and presents the principal
methods that are employed.
Aims and Objectives:
To provide an appreciation of the need for and use of clinical trials in
medical practice and an understanding of the principal statistical methods
required.
Syllabus:
Historical context and the need for randomization in the assessment of
treatments. The idea of bias. Patient selection, ethical constraints and
allocation to treatment. Power calculations. Methods for controlling bias
in assessing outcomes. Analysis of data from clinical trials: baselines
as covariates. Subgroups and multiple outcome variables. Protocol deviation
and "Analysis by Intention to Treat''. Crossover trials.
Reading:
D.G. Altman: Practical Statistics for Medical Research (Chapman
and Hall, 1991).
P. Armitage and G. Berry: Statistical Methods in Medical Research
(Blackwell, 1994).
S.J. Pocock: Clinical Trials: a Practical Approach (Wiley, 1983).
Assessment:
Assessment of course work (10%), mid-semester test (10%).
1.5 hour examination at end of Semester (80%).
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