6 points, SCA Band 2, 0.125 EFTSL
Postgraduate - Unit
Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.
The term "clinically proven", used throughout even the lay vernacular, highlights the high status of clinical trials in health research. This is because clinical trials provide the most robust evidence of the benefits of healthcare interventions; they are the 'gold standard' study design.
A solid understanding of clinical trials is a key requirement for anyone working in clinical research, or who need to interpret the results of clinical research.
This unit will equip students with the skills to formulate research questions, design appropriate clinical trials, select and recruit study subjects, conduct randomisation, analyse data, interpret findings, manage outcomes and consider issues of ethics, budget and quality assurance. It will also endow students with the skills to critically appraise clinical trials.
Upon successful completion of this unit, students will be able to:
- Examine the principles of clinical trials and understand their role in informing healthcare practice and policy.
- Critically analyse the theoretical approaches to clinical trials, including different types of clinical trials, and the strengths and limitations of each.
- Formulate a meaningful question that has relevance to clinical practice or public health, design the right trial for the question, and articulate this design in a study protocol.
- Critically appraise a published clinical trial in order to determine its validity or otherwise to real-life practice and policy.
- Explain the importance of communication between key stakeholders in clinical trials.
- Investigate the practical considerations of undertaking clinical trials, including planning, gaining ethics approval, recruitment and retention of subjects, measurement of outcomes and data analyses.
- Critical reflections (1,800 words - 10 x 180 words) (30% total) Online test (30 minutes) (10%)
- Exam (60 minutes) (20%)
- Study protocol (2,400 words) (40%) (Hurdle)
Alignment with learning outcomes
6 hours of teacher-directed learning activities per week, and 6 hours of self-directed study per week, plus two compulsory on-campus Block Days.
See also Unit timetable information
Off-campus attendance requirements
15 contact hours over 2 days.