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## EPIB3036 Introduction to Clinical Trials

### 15 creditsClass Size: 27

Module manager: Dr Sarah Brown
Email: medsbro@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2020/21

### Pre-requisite qualifications

EPIB5023M Introduction to Modelling or MATH2735 Statistical Modelling or equivalent.

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. Pre requisite knowledge of linear modelling is required. The module provides 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 the SAS software for trial analysis and nQuery software for sample size calculation.
- Introduce critical appraisal of trial documentation including 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:

- 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;
- 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);
- 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;
- Critically appraise clinical trial grant applications, protocols and reports and methodology papers;
- Explain sources of bias in clinical trials, including selection, performance, detection and attrition bias, and methods of avoidance;
- Construct and justify sample size calculations covering various designs and assumptions;
- Effectively apply descriptive and comparative methods of analysis to clinical trial data, understanding methods for handling protocol deviations and multiplicity;
- Apply statistical principles of clinical trials to quality assessment within systematic reviews and meta-analyses.

Skills outcomes
Statistical design, analysis, and reporting for clinical trials.
Use of SAS and nQuery software for trial design and analysis.

### Syllabus

The module will be delivered by Dr Rebecca Walwyn, Dr Sarah Brown, Ms Sarah Brown, Ms Helen Marshall, Ms Dena Cohen and other colleagues within the Clinical Trials Research Unit over 12 weeks, as a blend of face-to-face small group work, seminars 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 Workshop 12 2.00 24.00 Lecture 12 1.00 12.00 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 and workshops, 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 lecture/seminar and workshop topics.

### Opportunities for Formative Feedback

This will be done in a number of ways:

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.
A 10 minute individual presentation delivered to their peer-group around week 5 (set in week 1), critically appraising a trial paper, with feedback from the group and lecturer.

### Methods of assessment

Coursework
 Assessment type Notes % of formal assessment Assignment 2,000 word aims and methods section of a trial grant proposal 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 Online Time-Limited assessment 2 hr 00 mins 50.00 Total percentage (Assessment Exams) 50.00

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