Randomised Clinical Trials (RCTs): a multidisciplinary approach to teaching and research – Esther Wai Yin Chan
Randomised clinical trials (RCTs) generate important information about the effectiveness and safety of drugs, whether they are drugs yet to be on the market or already extensively used in the real-world. RCTs are implemented based on robust research methods to randomly allocate individuals to two or more groups to allow for comparisons of the groups, ideally with only the drug comparison being different between the groups (and patient characteristics being quite similar); and with all parties “blinded” to drug allocation to minimize subjective influence over the study results as much as possible. RCTs are high up in the hierarchy of quality of evidence because of these features and data from good quality RCTs are often mandated for clinical guideline recommendations, or drug formulary decisions to bring new drugs into hospitals for widespread use.
The RCT research methodology was adopted in both teaching and research, training undergraduate students how to apply their knowledge in the interdisciplinary context and apply these skills in clinical settings alongside our own research work.
We just completed a multi-centre RCT across six Accident and Emergency Departments of Hong Kong. The execution of the RCT was truly multidisciplinary, involving over 180 colleagues of different disciplines including pharmacists from the hospital and the Department of Health, nurses, doctors, psychiatrists, international collaborators; as well as hospital administrators, institutional review board members and independent safety review board members.
This is the forth RCT in the series and the first in Asia. RCTs really require an immense and broad set of skills and knowledge from many disciplines. I felt that there were many aspects that both undergraduate and postgraduate students could learn from multi-center RCTs, from regulatory aspects to engagement of study site colleagues, active patient recruitment, to how to respond to colleague’s questions. Under the Early Career Scheme Award, the Research Grants Council of Hong Kong provided a provision for researchers to engage in research related teaching through our proposal of an education plan to accompany the research proposal of the RCT. I found this a very valuable experience for myself as well as the students who took part.
For the five-year period of award, seven undergraduate students were trained in the undergraduate BPharm programme as part of their final year project, twelve students were trained as part of their summer research exchange programme from different disciplines including Biomedical Science, Chemistry and Pharmacy from international institutions including HKU, King’s College London, The University of Queensland, UCL, UC Davis, and HKU; and one PhD student completed his thesis based on this work.
The training provided to students broadened their understanding of the importance of research from first-hand experience. Students were trained in critical appraisal of the literature, research planning, data collection and analysis. Importantly, they learnt to appreciate the patience required for patient recruitment and research in general. The students also had the opportunity to work within a larger research team within the Centre for Safe Medication Practice and Research to gain experience in team-work and collaboration both at HKU and at the clinical study sites. Many aspects of research can be adapted in teaching and be a rewarding experience for all ─ students, teachers, researchers and clinical practitioners alike.