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2022/23 Taught Postgraduate Module Catalogue

BIOL5278M Pharmaceutical Development: Clinical

15 creditsClass Size: 10

Module manager: Dr Fiona Collinson
Email: f.j.collinson@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2022/23

Pre-requisite qualifications

Sufficient entry requirements to have been admitted to the above programme.

This module is mutually exclusive with

BIOL5267MBiopharmaceutical Development: Clinical

Module replaces

BIOL5277M: Pharmaceutical Development: Clinical

This module is not approved as an Elective

Module summary

The module will provide an outline to the principles of clinical trial design, ethical review and conduct in the settings of both small molecule and biologics development. The emphasis will be on understanding the practical issues that arise through real examples backed up with the relevant theory. It will expand on the introduction provided in the introductory Drug Discovery and Development Pathways module, providing grounding in the knowledge and skills required by those working in the pharmaceutical industry.

Objectives

On completion of this module, students should be able to:
• Outline how the data from preclinical/non-clinical studies are used to design a first-in-human study, including how to derive the starting dose
• Provide a more detailed overview of the key principles involved in each phase of clinical development (phase I-IV)
• Introduce approaches to statistical trial design that are of particular relevance to biologics development, including use of adaptive designs, biomarker stratification, and surrogate endpoints
• Provide an awareness of key elements of a clinical trial protocol, including identifying the research question, defining eligibility criteria, selecting appropriate endpoints, obtaining ethical approval and evaluating pharmacovigilance; and provide an awareness of how these processes are implemented in practice
• Provide an awareness of the many different types of data obtained within a clinical trial, how this is used throughout the trial, and how trial results are ultimately interpreted
• Provide an understanding of how clinical trials are run practically, via a site visit.
• Provide an awareness of the involvement of patients in developing clinical trials
• Provide practical training on Good Clinical Practice.
• Provide an understanding of how to develop a clinical development plan and the practical and ethical considerations that may impact such a plan.

Learning outcomes
On completion of the module students should be able to:
1. Explain, with examples, the core elements of a clinical trial protocol, including the ethical issues and requirements;
2. Critically appraise a clinical trial research proposal for a phase I trial including the ethical issues and requirements;
3. Explain, with examples, the application of statistical designs to a biologics 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.


Syllabus

The module will cover the following:
• How to use preclinical/non-clinical data to design a first-in-human study;
• Key principles of phase I to phase IV trials;
• Introduction to statistical trial design;
• Principal elements of clinical trial protocol development;
• Overview of trial data and interpretation;
• Patient involvement;
• Good Clinical Practice;
• Principle elements of a clinical development plan;
• The consideration of the ethical issues surrounding the involvement of human participants in clinical trials, and of the ethical review of clinical trials

Teaching methods

Delivery typeNumberLength hoursStudent hours
Seminars12.002.00
Seminars71.007.00
Tutorials41.506.00
Practicals13.003.00
Fieldwork13.003.00
Independent online learning hours37.00
Private study hours92.00
Total Contact hours21.00
Total hours (100hr per 10 credits)150.00

Private study

Students will be expected to complete questions/material started during the tutorials, they will be expected to read through and reflect upon material covered in the previous seminar and tutorial 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 seminar and tutorial topics.

Opportunities for Formative Feedback

This will be done in a number of ways:
• Student attendance and contribution to seminars 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;
• A 10 minute individual presentation delivered to their peer-group, presenting their clinical trial proposal, with feedback from the group and lecturer.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
ProjectDevelopment of a clinical trial synopsis following template considered in tutorial, and based on set research topic (T2DXR141).50.00
Oral PresentationGroup presentation covering components of a clinical development plan, considered in tutorial, and based on set research topic (T2DXR141)30.00
Tutorial PerformanceDevelopment of a lay summary, considered in tutorial and based on a set research topic (REOGLIO)20.00
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: 03/08/2022

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