# Unit information: Clinical Trials & Statistics in 2021/22

Unit name Clinical Trials & Statistics SOCSM0002 10 M/7 Academic Year (weeks 1 - 52) Professor. Chris Rogers Not open None None Bristol Medical School 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

• 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 multiple choice questions (MCQs) of a simple format (e.g. select the best answer from 4 or 5 options, true/false), contributing 10% each to the unit.
• 1 short answer question set, contributing 40% to the unit.

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

Written exam (contributing a total of 40% to the unit) consisting of:

• Short answer paper contributing 40% to the unit.

## Resources

If this unit has a Resource List, you will normally find a link to it in the Blackboard area for the unit. Sometimes there will be a separate link for each weekly topic.

If you are unable to access a list through Blackboard, you can also find it via the Resource Lists homepage. Search for the list by the unit name or code (e.g. SOCSM0002).

How much time the unit requires
Each credit equates to 10 hours of total student input. For example a 20 credit unit will take you 200 hours of study to complete. Your total learning time is made up of contact time, directed learning tasks, independent learning and assessment activity.