MMB8005 : Experimental Medicine & Therapeutics
- Offered for Year: 2024/25
- Module Leader(s): Dr Ruben Thanacoody
- Lecturer: Dr Simon Hill, Dr Stephen Erhorn, Dr Nan Lin, Mr Sean Scott, Prof. Ann Daly, Professor Ruth Plummer
- Owning School: Biomedical, Nutritional and Sports Scien
- Teaching Location: Newcastle City Campus
Semesters
Your programme is made up of credits, the total differs on programme to programme.
| Semester 1 Credit Value: | 20 |
| ECTS Credits: | 10.0 |
| European Credit Transfer System | |
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
Teaching Activities
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| Guided Independent Study | Assessment preparation and completion | 2 | 50:00 | 100:00 | Preparation of in-course assessment |
| Scheduled Learning And Teaching Activities | Lecture | 8 | 1:00 | 8:00 | Present in Person (PIP) lectures |
| Guided Independent Study | Directed research and reading | 10 | 8:00 | 80:00 | E-learning using Canvas; information delivery and formative feedback; supported by seminars |
| Scheduled Learning And Teaching Activities | Small group teaching | 2 | 1:00 | 2:00 | Present in person (PIP): Tutorials - revision and feedback session |
| Scheduled Learning And Teaching Activities | Small group teaching | 10 | 1:00 | 10:00 | Present in person (PIP) seminars |
| Total | 200:00 |
Teaching Rationale And Relationship
Basic knowledge and information will be provided by e-learning via Canvas. Weekly interactive seminars, delivered in person, 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 written coursework.
Assessment Methods
The format of resits will be determined by the Board of Examiners
Other Assessment
| Description | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|
| Design/Creative proj | 1 | M | 50 | Written report, 2000 words, based on study design and problem-solving. |
| Design/Creative proj | 1 | M | 50 | Powerpoint 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
- Timetable Website: www.ncl.ac.uk/timetable/
- MMB8005's Timetable