Unit information: Clinical Trials & Statistics in 2015/16

Unit name	Clinical Trials & Statistics
Unit code	SOCSM0002
Credit points	10
Level of study	M/7
Teaching block(s)	Teaching Block 1 (weeks 1 - 12)
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 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 ‘general’ ethical principles of clinical research (including some historical and legal perspective on ethics) and the UK research governance framework and the EU directive governing the conduct of clinical trials will be covered.

Intended Learning Outcomes

Students successfully completing this module will be able to:

• 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

• Web-based lectures, tutorials and practical demonstrations (in powerpoint-with-audio format)
• Online discussion forum(s)
• Self-directed study
• Hands-on practical workshops held in Bristol.

Assessment Information

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

• 2 sets of multiple choice questions (MCQs) of a simple format (e.g. select an answer from a short number of options, true/false), each contributing 10% to the unit, giving a total of 20%.
• 1 short essay contributing 20% to the unit.
• 2 short answer question sets or extended MCQs, each contributing 10% to the unit, giving a total of 20%.

Please note that students will be given formative feedback on all coursework assessment.

2. Written exam (contributing a total of 40% to the unit and taken in Bristol) consisting of:

• 1 essay contributing 20% to the unit.
• 1 sets of MCQs contributing 20% to the unit.

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

1. DG Altman – Practical statistics for medical research – Chapman and Hall (1991)
2. M Bland – An introduction to medical statistics (2nd edition) – Oxford Medical Publications (1996)
3. MJ Campbell and D Machin – Medical statistics. A common sense approach (2nd edition) – Wiley (1993)
4. A Petrie and C Sabin – Medical statistics at a Glance – Blackwell (2000)
5. SJ Pocock – Clinical Trials – A practical approach – Wiley (1983)