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Unit information: Clinical Trials & Statistics in 2019/20

Please note: Due to alternative arrangements for teaching and assessment in place from 18 March 2020 to mitigate against the restrictions in place due to COVID-19, information shown for 2019/20 may not always be accurate.

Please note: you are viewing unit and programme information for a past academic year. Please see the current academic year for up to date information.

Unit name Clinical Trials & Statistics
Unit code SOCSM0002
Credit points 10
Level of study M/7
Teaching block(s) Academic Year (weeks 1 - 52)
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

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 details

  • Web-based lectures (in Powerpoint-with-audio format) and tutorials
  • Online discussion forum(s)
  • Self-directed study
  • Face-to-facetutorials held in Bristol.

Assessment Details

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 exams (contributing a total of 40% to the unit and taken in Bristol) consisting of:

  • Short answer paper contributing 25% to the unit.
  • MCQ paper contributing 15% to the unit.

Reading and References

DG Altman – Practical statistics for medical research – Chapman and Hall (1991)

M Bland – An introduction to medical statistics (2nd edition) – Oxford Medical Publications (1996)

MJ Campbell and D Machin – Medical statistics. A common sense approach (2nd edition) – Wiley (1993)

A Petrie and C Sabin – Medical statistics at a Glance – Blackwell (2000)

SJ Pocock – Clinical Trials – A practical approach – Wiley (1983)

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