The University of Southampton
Courses

# 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

#### Module Aims

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

#### Learning Outcomes

##### Learning Outcomes

Having successfully completed this module you will be able to:

• 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
• Able to use the material covered in the course to contribute statistical expertise to the design of a new RCT

### 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

TypeHours
Independent Study57
Teaching18
Total study time75

Greenhalgh T (1997). How to read a paper.

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

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

### Assessment

#### Summative

MethodPercentage contribution
Coursework 50%
Coursework 50%

#### Referral

MethodPercentage contribution
Coursework assignment(s) %

#### Repeat Information

Repeat type: Internal & External

### Costs

#### Costs associated with this module

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.

In addition to this, students registered for this module typically also have to pay for:

##### Books and Stationery equipment

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

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.

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