Postgraduate Course: Clinical Trial Designs (MCLM11096)
Course Outline
| School | Deanery of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
| Course type | Online Distance Learning |
Availability | Available to all students |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | This course will focus on a variety of trial designs that may be used in phase three randomised control trials (RCTs). An appropriate trial design must be selected to ensure the RCT addresses a clinical research question effectively. The CONSORT framework underpins the learning of designs taught.
This course will provide students with the skillset to demonstrate an understanding of a variety of advanced trial designs, and to critically evaluate and report on the design at critical phases (planning, trial conduct, analysis and reporting). |
| Course description |
This course will focus on the different types of trial designs that may be used in an RCT. In particular, students will develop their knowledge on a range of trial designs used in phase III RCTs, including cross-over, factorial and adaptive trial designs. Throughout the course, students will be encouraged to critically evaluate the benefits, challenges and appropriateness of a chosen trial design to answer a specific clinical research question.
This course will consist of a programme of lectures, peer discussion groups, and independent learning with a required reading list. Students must participate online throughout the course and will have access to supportive tutorials. Students will apply their learning through discussion with peers, online questions, individual projects and reflection.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | Laptop and Internet connection - which all online CT students require for any part or all of the programme. |
Information for Visiting Students
| Pre-requisites | None |
Course Delivery Information
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| Academic year 2025/26, Available to all students (SV1)
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Quota: None |
| Course Start |
Flexible |
Timetable |
Timetable |
| Learning and Teaching activities (Further Info) |
Total Hours:
200
(
Lecture Hours 10,
Seminar/Tutorial Hours 2,
Online Activities 70,
Feedback/Feedforward Hours 10,
Formative Assessment Hours 10,
Revision Session Hours 2,
Programme Level Learning and Teaching Hours 4,
Directed Learning and Independent Learning Hours
92 )
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| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
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| Additional Information (Assessment) |
Written exam 0%, Coursework 100%, Practical exam 0%
Assessment will be a combination of a final written assignment, other assessed activities and group work |
| Feedback |
Online questions: For multiple choice questions the student will be provided with the correct answer alongside an explanation of this. For the two free text questions individual feedback will be provided.
GDB: The students will be given feedback in terms of how well they engaged with their peers and the overall relevance of posts to the subject matter. They will also be given comments on the strength of the evidence base and level of critical analysis in evidence. Finally, timeliness and online visibility will also be remarked on.
Individual report: General feedback for the individual report will be in respect of general formatting and referencing, the skill with which they introduce the trial and summarise the findings.
More substantial feedback will be in terms of how well the report adheres to CONSORT. Substantive comments will also be provided on the strength of the justification for decisions made and lessons learned (justifications and lessons should demonstrate evidence of critical analysis and be substantiated with relevant evidence). Finally, the student's ability to summarise the overall strengths and limitations of the trial will be remarked upon.
Reflective IP: The student will be given feedback on their reflection of the group work in the GDB, as well as their own personal growth in understanding of the trial. The use and guidance of reflective tools and strategies will be commented on as well as depth of reflection. |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Justify a clinical trial design that most effectively addresses the research question by maximising efficiency, while also best addressing statistical and logistical issues.
- Comprehensively report on clinical trials by clearly, completely, and transparently communicating the trial's practical, statistical, and logistical aspects, ensuring adherence to rigorous standards for well-conducted research.
- Communicate the practical, statistical, and logistical aspects of each stage of the trial: planning; conduct; analysis; and reporting in respect of the design type.
- Identify the key aspects of different trial types covered in this course, and their associated challenges.
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Additional Information
| Graduate Attributes and Skills |
Research and enquiry (problem-solving, analytical thinking, critical thinking, knowledge integration and application handling complexity and ambiguity, digital literacy, numeracy)
Enquiry and lifelong learning
Communication |
| Keywords | trial design,randomised clinical trials,CONSORT |
Contacts
| Course organiser | Dr Afshan Dean
Tel: (0131 6)51 5440
Email: Afshan.dean@ed.ac.uk |
Course secretary | Ms Rebecca Sewell
Tel: (0131 6)51 7112
Email: Rebecca.Sewell@ed.ac.uk |
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