MMB8005 : Experimental Medicine & Therapeutics
- Offered for Year: 2019/20
- Module Leader(s): Dr Ruben Thanacoody
- Lecturer: Dr Nina Wilson, Dr Stephanie Scott, Miss Helen Mossop, Professor Simon Thomas, Professor Ann Daly, Mr Alan Hochberg, Professor Ruth Plummer, Dr Simon Hill, Dr Erhorn
- Owning School: FMS Graduate School
- Teaching Location: Newcastle City Campus
|Semester 1 Credit Value:||20|
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
Interpreting, presenting and publishing results of clinical trials
Drug licensing in the EU and USA
Critical appraisal and economic evaluation
|Guided Independent Study||Assessment preparation and completion||1||50:00||50:00||Preparation for Exams|
|Scheduled Learning And Teaching Activities||Lecture||5||1:00||5:00||Lectures; face-to-face|
|Guided Independent Study||Assessment preparation and completion||1||40:00||40:00||Preparation of in-course assessment|
|Scheduled Learning And Teaching Activities||Practical||2||2:00||4:00||Practical sessions where students write a clinical trial protocol and patient information sheet|
|Guided Independent Study||Directed research and reading||20||4:00||80:00||E-learning in specified weeks; information delivery and formative feedback; supported by seminars|
|Scheduled Learning And Teaching Activities||Small group teaching||1||2:00||2:00||Tutorials including revision and feedback session; face-to-face|
|Scheduled Learning And Teaching Activities||Small group teaching||7||2:00||14:00||Seminar 2 hours in length; face-to-face|
|Scheduled Learning And Teaching Activities||Small group teaching||5||1:00||5:00||Seminars 1 hour in length; face-to-face|
Teaching Rationale And Relationship
Basic knowledge and information will be provided by e-learning via Blackboard. 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 and preparing for examinations.
The format of resits will be determined by the Board of Examiners
|Written Examination||60||1||A||60||Choice of three essay questions. Students will answer one question only.|
|Design/Creative proj||1||M||40||Written report, 2000 words, based on study design and problem-solving.|
Assessment Rationale And Relationship
The essay-based written examination will test in-depth understanding and knowledge of material covered during the course relating directly to the intended knowledge outcomes, and also the ability to articulate this knowledge clearly in writing. The written report will test achievement of the stated intended skills outcomes and ability to apply these skills to a specific case study.