Faculty of Medical Sciences Online Learning

CHS8002

CHS8002 : Drug Development from First-in-Man to Bedside (E-learning)

  • Offered for Year: 2016/17
  • Module Leader(s): Dr Ruben Thanacoody
  • Lecturer: Prof. Simon Thomas, Mrs Alison Clapp, Dr Simon Hill
  • Owning School: FMS Graduate School
  • Teaching Location: Off Campus
Semesters
Semester 1 Credit Value: 5
Semester 2 Credit Value: 15
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. The module presents knowledge and experience from clinical experts and researchers drawn from both academic institutions and the pharmaceutical industry.

Outline Of Syllabus

The module covers the following topics:
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
CategoryActivityNumberLengthStudent HoursComment
Guided Independent Study Assessment preparation and completion 4 17:00 68:00  
Guided Independent Study Directed research and reading 10 6:00 60:00 Online content with links to other relevant online material
Guided Independent Study Skills practice 1 2:00 2:00 Use of software (statistics packages and PCap)
Guided Independent Study Reflective learning activity 10 2:00 20:00 Reflective journal
Guided Independent Study Student-led group activity 5 2:00 10:00 Peer-review
Guided Independent Study Independent study 10 2:00 20:00 Supplemental reading
Guided Independent Study Online Discussion 10 2:00 20:00  
Total       200:00  
Teaching Rationale And Relationship

The module will be delivered by e-learning via blackboard VLE. The curriculum will be delivered through a series of guided learning opportunities including e-based activities generating knowledge for the summative assessment, enabling students to explain and analyse all aspects of the clinical phases of drug development. Online materials guide the students towards analysis of clinical research data (including statistical analysis) as well as critical appraisal of clinical trial results. The discussion boards (student-led activity) allow peer review of each other’s appraisal as well as discussion of online topic activities similar to the discussion generated by a clinical trial team. The course material will provide students with current specialist knowledge from experts in the field of clinical research and drug development.

Assessment Methods

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

Other Assessment
DescriptionSemesterWhen SetPercentageComment
Design/Creative proj 2 M 25 Written report max 2000 words of a clinical trial protocol
Essay 2 M 25 Essay on a topic from the course. 2000 Words Max.
Prob solv exercises 2 M 15 5 short exercises at the end of specific topics to feed forward to the creative project and written assessments.
Portfolio 2 M 10 Discussion board: participation mark (collaborative activity and web journal)
Written exercise 2 M 25 Data analysis and presentation via submission of slides to Blackboard.
Formative Assessments
DescriptionSemesterWhen SetComment
PC Examination 3 M MCQ Statistical data questions: Self-assessment with feedback.
Assessment Rationale And Relationship

Students will be asked to prepare work for formative and summative assessment and submit these for assessment through Blackboard.

The work for summative assessment will use the knowledge acquired, their individual feedback, notes and other sources. Student work will be submitted and feedback given electronically via Blackboard. The web journal and the discussion board interaction will encourage the students to reflect on their learning journal and test the student’s comprehension, breadth and application of their knowledge base acquired throughout the module. 

The presentation will involve analysis of a trial dataset and submission of Powerpoint slides and abstract for assessment; this tests the student’s ability to analyse and synthesise data (analytical skills) for a scientific presentation and the level of their understanding of the subject in the context of a particular example

Writing skills, critical appraisal and overall understanding of the course content will be summatively assessed by the written report and final end-of-course essay.

Reading Lists

Timetable