Unit information: Clinical Trials and Statistics in 2020/21

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

Description including Unit Aims

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.

Intended Learning Outcomes

• Describe the key elements of a well-designed research study.
• Describe the common pitfalls when designing and conducting research and explain how they can be avoided.
• Define research hypotheses clearly and choose a suitable research design to address these.
• Decide on an appropriate statistical analysis method to apply and use.
• Carry out simple statistical analyses and interpret the output produced.

Teaching Information

• Synchronous and asynchronous lectures; tutorials
• Online discussion forum(s)
• Self-directed study

Assessment Information

Coursework (contributing a total of 60% to the unit) consisting of:

• 2 sets of on-line multiple choice questions (MCQs) (e.g. select the best answer from 4 or 5 options, true/false), contributing 10% to the unit.
• 1 short answer question set contributing 40% to the unit.
• Presentation on a unit-related topic, contributing 10% to the unit.

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:

• Essay paper

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.

Reading and References

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)