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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Clinical Trials in Special Populations (20 credit) (MCLM11023)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryThis 20-credit elective will run for 10 weeks and builds on the foundation of knowledge and skills attained in the Year 1 Clinical Trials programme courses, 'Introduction to Clinical Trials' and 'Good Clinical Practice, Ethics and Regulatory Issues'. Special focus will be on patients with additional needs or in special circumstances such as children, the elderly, prisoners and disabled individuals.
Course description "One size does not fit all" and this is particularly true of clinical trials in special populations.

Researchers face a difficult balance between 'gatekeeping' for people who are not able to consent or protect their own interests, and a necessity to include a generalisable sample and answer important questions relevant to specific populations. If researchers did not include special populations, a clear gap in knowledge would result.

We will begin the course by looking at what makes a group of individuals a 'special', 'vulnerable' or 'underrepresented' population in clinical research; exploring both intrinsic and situational factors. Each unit will then focus on a number of special populations and topical issues, exposing the course participants to trials of populations with different demographics, clinical conditions and research settings.

Research with special populations is challenging. We absolutely need better clinical trials with these populations. Course participants will have the opportunity to see how research with special populations has implications for trial design, consent, risk assessments and safety reporting; and how consideration needs to be given to recruitment, retention and adherence.

This course will include a range of 'real-life' research challenges and present opportunities for the development of potential strategies and solutions as presented in the following 5 units:

- Unit 1 - Introduction to Special Populations and Age
- Unit 2 - Capacity, Mental Health and Learning Disabilities
- Unit 3 - Prisons and Emergency Critical Care
- Unit 4 - Sex, Pregnancy and Ethnicity
- *Unit 5a - Clinical Trials and Rare Diseases
- *Unit 5b - Outsourcing Clinical Trials
*These units of study are created by the participants in a 'flipped classroom' approach to learning.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Additional Costs 0
Information for Visiting Students
High Demand Course? Yes
Course Delivery Information
Academic year 2023/24, Not available to visiting students (SS1) Quota:  None
Course Start Flexible
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Seminar/Tutorial Hours 5, Online Activities 100, Feedback/Feedforward Hours 40, Formative Assessment Hours 12, Summative Assessment Hours 10, Revision Session Hours 8, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 21 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key points. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.

Pair project (including peer assessment): 30%
Group project: 30%
Individual project: 40%
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Critically explore the legal, ethical and practical implications of recruiting children and young people into clinical trials including differences through throughout the developed nations in the UK.
  2. Critically appraise the legal, ethical and practical implications of recruiting adults who lack capacity into clinical trials including differences throughout the developed nations in the UK (including mental health, learning disabilities and emergency/critical care situations).
  3. Reflect on the exclusion and under-representation of certain populations (including elderly people, women, prisoners, ethnic and racial minorities, and rare diseases).
  4. Debate ethical and regulatory implications of research in special settings (including emergency situations, pregnancy, prisons and developing countries).
  5. Design strategies for overcoming recruitment challenges in special populations.
Reading List
Additional Information
Graduate Attributes and Skills Within the work to be undertaken this course will provide course participants with the opportunity to develop or further develop key graduate attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed and curious learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Engage in reflective practice and self-development
- Collaborate with others, capitalising on their different thinking, experience and skills
- Communicate (written, oral, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
KeywordsClinical trials,legal,ethics,adults lacking capacity,children,rare diseases
Course organiserProf Stuart Ralston
Tel: (0131 6)51 8743
Course secretaryMiss Suzanne Newall
Tel: (0131 6)50 2022
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