## MATH3860 Introduction to Clinical Trials

### 15 creditsClass Size: 40

Module manager: Dr Duncan Wilson
Email: D.T.Wilson@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2024/25

### Pre-requisite qualifications

MATH2715 OR MATH2735

Module replaces

EPIB3036

This module is not approved as a discovery module

### Module summary

The module will provide an outline to the statistical principles of clinical trial design, conduct, analysis and reporting. The emphasis will be on understanding the practical issues that arise through real examples backed up with the relevant theory. It will build on courses on linear modelling providing a grounding in the basic specialist knowledge and skills required by a statistician working within a Clinical Trials Unit.

### Objectives

The objectives of this module are to:
- Develop a knowledge of the statistical aspects of the design, conduct, analysis, and reporting of clinical trials.
- Develop an understanding of software suitable for trial analysis and for sample size calculation.
- Introduce critical appraisal of trial documentation such as protocols, grant applications and research papers.
- Enable students to apply the concepts of statistical design and analysis to the formulation of a clinical trial.
- Enable students to interpret and communicate trial analyses and methodology to a statistical audience.

Learning outcomes
On completion of this module, students should be able to:
1. Explain, with examples, the application of statistical principles to clinical trials, including when writing the trial protocol and statistical analysis plan and in designing data collection tools and the database etc.;
2. Demonstrate a critical awareness of the main issues arising from Phase III clinical trial designs (including parallel-group, crossover, factorial, repeated-measures and cluster-randomised trial designs);
3. Identify and justify the choice of design and analysis in a real example, applying principles of experimental design modified by practical, ethical and economic constraints;
4. Critically appraise clinical trial grant applications, protocols and reports and methodology papers;
5. Explain sources of bias in clinical trials, including selection, performance, detection and attrition bias, and methods of avoidance;
6. Construct and justify sample size calculations covering various designs and assumptions;
7. Effectively apply descriptive and comparative methods of analysis to clinical trial data, understanding methods for handling protocol deviations and multiplicity;
8. Apply statistical principles of clinical trials to quality assessment within systematic reviews and meta-analyses.

### Syllabus

The module will be delivered by the Clinical Trials Research Unit over 12 weeks, as a blend of face-to-face small group work and lectures, online written material, online formative questions, practical sessions and workshops. The course will draw extensively on the research interests and past experience of the lecturers.

The course will cover the following subjects:
- Basic concepts in clinical trials
- Choice of trial designs, including analysis implications
- Methods of random allocation of treatments to patients
- Definition and handling of protocol deviations in the analysis
- Sample size considerations
- Implications of multiple comparisons
- Quality assessment in systematic reviews and meta-analyses
- Practical issues in randomised trials

### Teaching methods

 Delivery type Number Length hours Student hours Lecture 12 1.00 12.00 Practical 12 2.00 24.00 Independent online learning hours 34.00 Private study hours 80.00 Total Contact hours 36.00 Total hours (100hr per 10 credits) 150.00

### Private study

Students will be expected to complete questions/material started during the practicals, they will be expected to read through and reflect upon material covered in the previous lecture and practical session, and to read relevant material from the recommended reading list provided (a mix of paper-based and VLE materials). Students will have set reading tasks in preparation for lectures and practical topics.

### Opportunities for Formative Feedback

Student attendance and contribution to lectures and tutorials/practical sessions; Access logs for the online material on the VLE. Despite this being self-paced, reasonable aims will be defined for progress with the material; Completion of and group discussion of practical questions during contact time; Recording and monitoring of progress with individual online questions/answers within QuestionMark in the VLE with automated feedback that will be marked as a formative assessment.

### Methods of assessment

Coursework
 Assessment type Notes % of formal assessment Project 2,000 word aims and methods section of a trial grant proposal and a software task 50.00 Total percentage (Assessment Coursework) 50.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Exams
 Exam type Exam duration % of formal assessment Standard exam (closed essays, MCQs etc) 2 hr 50.00 Total percentage (Assessment Exams) 50.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated