The University of Southampton

MATH6151 Clinical Trials

Module Overview

This module provides an introduction to the statistical challenges arising in planning and conducting clinical trials. The main topics will cover: Clinical Trials of Parallel or cross-over design; Randomization, Treatment Comparison and Confidence Intervals, the use of Baseline Characteristics, Multiplicity in trials, the Protocol, deciding the Sample size, Blinding, Reviewing a Paper reporting a clinical trial, Systematic Reviews and Meta-Analysis, Monitoring trials.

Aims and Objectives

Aim

Having successfully completed this module, you will be able to:

• To introduce students to the statistical challenges of clinical comparison of two or more treatments in human subjects

Knowledge and Understanding

Having successfully completed this module, you will be able to demonstrate knowledge and understanding of:

• Familiar with terminology of the area
• Able to contribute the statistical elements to design a standard parallel group trials
• Able to carry out standard power calculation for continuous normal and binary outcomes in two group parallel trials
• Aware of the importance of specifying primary outcomes and planned analysis in the protocol
• Able to critically review a paper reporting a randomized controlled trial.
• Able to analyze a AB/BA cross-over experiment with a continuous normally distributed outcome
• Aware of the uses and limitations of the AB/BA cross-over design
• Aware of the rationale and objectives of meta-analyses

Syllabus

• Clinical Trials of Parallel or cross-over design
• Randomization
• Treatment Comparison and Confidence Intervals
• the use of Baseline Characteristics
• Multiplicity in trials, the Protocol
• deciding the Sample size
• Blinding
• Reviewing a Paper reporting a clinical trial
• Systematic Reviews and Meta-Analysis
• Monitoring trials

Learning and Teaching

Teaching and learning methods

18 lectures, self-study

Resources and reading list

Greenhalgh T (1997). How to read a paper. BMJ Publishing Group.

Pocock S (1983) - Clinical Trials: A Practical Approach (Wiley) Statistical principles for clinical trials.

Strike P W (1991). Statistical Methods in Laboratory Medicine, Butterworth

Assessment

Assessment methods

Assessment Method Hours % contribution to final mark Feedback
Coursework   100% Individual feedback sheets

Referral Method: By set coursework assignment(s)

Method of Repeat Year: Repeat year internally. Repeat year externally.

Costs

Costs associated with this course

Students are responsible for meeting the cost of essential textbooks, and of producing such essays, assignments, laboratory reports and dissertations as are required to fulfil the academic requirements for each programme of study.

Please also ensure you read the section on additional costs in the University’s Fees, Charges and Expenses Regulations in the University Calendar available at www.calendar.soton.ac.uk.

Course texts are provided by the library and there are no additional compulsory costs associated with the module.