Unit name | Clinical Trials and Statistics |
---|---|
Unit code | SOCSM0017 |
Credit points | 10 |
Level of study | M/7 |
Teaching block(s) |
Teaching Block 2 (weeks 13 - 24) |
Unit director | Professor. Chris Rogers |
Open unit status | Not open |
Pre-requisites |
NONE |
Co-requisites |
NONE |
School/department | Bristol Medical School |
Faculty | Faculty of Health Sciences |
This unit will provide an overview of the different types of research design, with particular emphasis on clinical trials.
It aims to provide students with a good understanding of the underlying principles of clinical trial design and knowledge of the appropriate use of statistics. Examples will be taken from cardiovascular disease and perfusion studies where possible, nonetheless the principles and techniques to be discussed apply equally to other areas of science and medicine.
Students will gain an understanding and appreciation of how to conduct clinical trials successfully (e.g. appropriate data collection and case report form design for clinical studies, study size and power calculations, randomisation methods) and how to avoid common pitfalls (e.g. bias and confounding and how to minimize them).
Essential concepts underlying statistical methods will be introduced (e.g. data distributions, hypothesis testing, confidence intervals, t-tests, non-parametric methods, chi-squared tests, odds ratios, relative risks etc). Students will gain sufficient knowledge to be able to identify which statistical analysis method should be employed. Mathematical formulae however, will be kept to a minimum. Importantly, the UK research governance framework and the EU directive governing the conduct of clinical trials will be covered.
Coursework (contributing a total of 60% to the unit) consisting of:
Please note that students will be given formative feedback on all coursework assessments.
Written exam (contributing a total of 40% to the unit) consisting of:
The overall pass-mark for the unit will be 50%. However, students will be required to reach a minimum standard in both their coursework and their written exam; only 5% compensation between the total coursework element and the total exam element will be allowed.
A Petrie and C Sabin – Medical statistics at a Glance – Blackwell (2000)
MJ Campbell and D Machin – Medical statistics. A common sense approach (2'nd' edition) – Wiley (1993)
M Bland – An introduction to medical statistics (2'nd' edition) – Oxford Medical Publications (1996)
DG Altman – Practical statistics for medical research – Chapman and Hall (1991)
SJ Pocock – Clinical Trials – A practical approach – Wiley (1983)