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2022/23 Taught Postgraduate Module Catalogue

BIOL5267M Biopharmaceutical Development: Clinical

10 creditsClass Size: 25

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

A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.

Pre-requisites

BIOL5164MBiopharmaceutical Development Pathway

This module is not approved as an Elective

Module summary

The module will provide an outline to the principles of clinical trial design and conduct in the setting of 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 Biopharmaceutical Development Pathway module, and link the Pre-Clinical Drug Development and Commercialisation of biopharmaceuticals modules, providing grounding in the basic specialist knowledge and skills required by those working in the biopharmaceutical industry.

Objectives

The aims of the module are to:
- Outline how the data from 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, 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.

Learning outcomes
On completion of the module students should be able to:
- Explain, with examples, the core elements of a clinical trial protocol
- Critically appraise a clinical trial research proposal for a phase I trial
- Explain, with examples, the application of statistical designs to a biologics research question
- Explain the key data reports produced through the lifetime of a clinical trial and how these are used
- Construct a lay summary of a clinical trial research protocol


Syllabus

The module will cover the following:
- How to use 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

Teaching methods

Delivery typeNumberLength hoursStudent hours
Fieldwork12.002.00
Seminar91.009.00
Tutorial22.004.00
Tutorial31.003.00
Independent online learning hours25.00
Private study hours57.00
Total Contact hours18.00
Total hours (100hr per 10 credits)100.00

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.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
EssayDevelopment of a clinical trial research proposal following template considered in tutorial and based on set research topic.70.00
ReportDevelopment of a lay summary of the study described in the clinical trial research proposal.30.00
Total percentage (Assessment Coursework)100.00

Resits will be examined by an essay question as it is not possible to repeat the same work.

Reading list

The reading list is available from the Library website

Last updated: 25/10/2022

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