2024/25 Taught Postgraduate Module Catalogue

OGDS5202M Clinical Trials

15 creditsClass Size: 150

Module manager: Andrew Hall
Email: A.Hall2@leeds.ac.uk

Taught: 1 Jan to 28 Feb, 1 Jan to 28 Feb (adv year) View Timetable

Year running 2024/25

Pre-requisite qualifications

Students are required to meet the programme entry requirements prior to studying the module

Module replaces

None

This module is not approved as an Elective

Module summary

The module will provide an outline to the 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 provide a grounding in the basic specialist knowledge and skills required by a non-statistician working on phase II/III clinical trials.

Objectives

The module will provide an outline to the principles of clinical trial design and conduct in the setting of drug development. The emphasis will be on understanding the practical issues that arise through real examples backed up with the relevant theory.

The aims of the module are to provide:

- An awareness of key elements of a clinical trial protocol, including identifying the research question, defining eligibility criteria, selecting appropriate endpoints, and evaluating pharmacovigilance; and provide an awareness of how these processes are implemented in practice;
- A detailed overview of the key principles involved in each phase of clinical development (phase II-III);
- An introduction of approaches to statistical trial design that are of particular relevance to drug development, including use of adaptive designs, biomarker stratification, and surrogate endpoints;
- An awareness of the many different types of data obtained within a clinical trial, how this is used throughout the trial (including in trial oversight), and how trial results are ultimately reported and interpreted;
- An understanding of how clinical trials are planned and run practically.
- An awareness of the involvement of patients in developing clinical trials;
- Practical training on Good Clinical Practice.

Learning outcomes
On successful completion of the module students will be able to

1. Explain, with examples, the core elements of a clinical trial protocol;
2. Critically appraise a clinical trial research proposal for a phase II/III drug trial;
3. Explain, with examples, the application of statistical designs to a research question;
4. Explain the key data reports produced through the lifetime of a clinical trial and how these are used;
5. Construct a lay summary of a clinical trial research protocol/report;
6. Describe the lifecycle of a clinical trial from grant application to final trial report.

Syllabus

Indicative content for this module includes:

1. Key principles of phase II to phase III trials
2. Introduction to statistical trial design
3. Principal elements of clinical trial protocol development
4. Overview of trial data and interpretation
5. Patient involvement
6. Good Clinical Practice

Teaching methods

Delivery type	Number	Length hours	Student hours
Discussion forum	6	2.00	12.00
WEBINAR	1	1.50	1.50
WEBINAR	5	1.00	5.00
Independent online learning hours			42.00
Private study hours			89.50
Total Contact hours			18.50
Total hours (100hr per 10 credits)			150.00

Private study

Across each week of learning students will actively engage with pre-prepared teaching and learning resources which scaffold learners to achieve learning outcomes (independent online learning). Each week follows a set pattern of acquiring knowledge which is then applied to a substantive activity which will usually be authentic to real-world application. Weekly asynchronous discussions (such as discussion boards) allow for peer-to-peer and peer-to-tutor discussion which supports completion of the substantive activity. At the end of each week of learning students consolidate their learning through reflective activities and a weekly live webinar session with the module tutor. Each unit also provides students with the opportunity for exploration and self-directed learning as is expected at masters level (private study).

Opportunities for Formative Feedback

The module’s digital learning materials provide regular opportunities for participants to check their understanding and gain feedback (e.g., case studies with short answer questions and automated feedback, MCQs with detailed feedback on correct/incorrect answers).

The individual unit webinars and discussion forums provide opportunities for formative feedback from peers and tutors.

Tutors will also provide whole-group feedback on tasks completed as part of their directed independent learning.

Students will be told of the assessment at the start of the module and will be provided with opportunities to ask questions to teaching staff before starting on the assignment.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Essay or Dissertation	Structured short answer questions on a clinical trial proposal	100.00
Total percentage (Assessment Coursework)		100.00

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

Reading list

The reading list is available from the Library website

Last updated: 18/11/2024

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