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Module

MMB8005 : Experimental Medicine & Therapeutics

  • Offered for Year: 2020/21
  • Module Leader(s): Dr Ruben Thanacoody
  • Lecturer: Dr Simon Hill, Dr Stephen Erhorn, Dr Nina Wilson, Mr Sean Scott, Miss Helen Mossop, Professor Ann Daly, Mr Alan Hochberg, Professor Ruth Plummer
  • Owning School: FMS Graduate School
  • Teaching Location: Newcastle City Campus
Semesters
Semester 1 Credit Value: 20
ECTS Credits: 10.0

Aims

The module aims to develop the students’ knowledge and understanding of the pharmacological and toxicological principles relevant to drug discovery and development, of the key principles involved in developing a drug from first use in man to licensing and early clinical use, and of the design, conduct and regulation of clinical trials in humans.

Outline Of Syllabus

The module covers the following topics, delivered through a series of lectures and formative assessments delivered through e-learning, supported by weekly interactive face-to-face seminars.

UK Research Infrastructure, Research Networks

Research governance and ethics, Good clinical practice

Clinical phases of drug development, phase I-IV trials

Clinical trial design

Statistical analysis of data

Patient recruitment, data collection and management

Monitoring safety

Interpreting, presenting and publishing results of clinical trials

Drug licensing in the EU and USA

Critical appraisal and economic evaluation

Post-marketing surveillance

Teaching Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

Teaching Activities
Category Activity Number Length Student Hours Comment
Structured Guided LearningLecture materials101:0010:00Non-synchronous online: pre-recorded
Guided Independent StudyAssessment preparation and completion250:00100:00Preparation of in-course assessment
Guided Independent StudyDirected research and reading108:0080:00E-learning using Ngage platform; information delivery and formative feedback; supported by seminars
Scheduled Learning And Teaching ActivitiesSmall group teaching21:002:00Present in person: Tutorials - revision and feedback session
Scheduled Learning And Teaching ActivitiesSmall group teaching81:008:00Present in person: Seminars
Total200:00
Teaching Rationale And Relationship

Basic knowledge and information will be provided by e-learning via Canvas. Weekly interactive seminars, delivered face-to-face, will provide activities and tasks which will encourage students to reflect individually on their previous week’s learning. Students will be asked to work in small groups and use that knowledge to solve problems or undertake tasks relating to different aspects of clinical trials in man such as writing a clinical trial protocol or write a patient information sheet. Seminars also provide an opportunity to develop other skills including interpersonal and oral communication, collaboration and information literacy.
Private study is used for self-directed learning including further reading, preparation for the seminars, undertaking a piece of written coursework.

Assessment Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Design/Creative proj1M50Written report, 2000 words, based on study design and problem-solving.
Design/Creative proj1M50Powerpoint poster presentation based on data analysis and problem-solving
Assessment Rationale And Relationship

The written report will test achievement of the stated intended skills outcomes and ability to apply these skills to a specific case study.

The data analysis coursework will test the ability to perform statistical analysis on a clinical trial dataset and summarise the results as a poster for a scientific audience. This is intended to prepare students for their research project.

Reading Lists

Timetable