Embedding principles of research ethics and experimental design in a physiology-based curriculum through the systematic review and meta-analysis of clinical trial data.

Physiology 2019 (Aberdeen, UK) (2019) Proc Physiol Soc 43, PC070

Poster Communications: Embedding principles of research ethics and experimental design in a physiology-based curriculum through the systematic review and meta-analysis of clinical trial data.

S. C. Land1, D. Booth1

1. School of Life Sciences, University of Dundee, Dundee, United Kingdom.

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Biomedical education aims to equip students with subject-level knowledge that can be combined with critical, analytical and practical skills to evaluate questions relevant to health and healthcare. To develop these skills in combination, we have developed a practical exercise aimed at undergraduate physiology, pharmacology and biomedical science students that promotes reflection on the post-war history of clinical trial regulation whilst training them in the evaluation of clincial studies using a standardised systematic review, data extraction and meta-analysis method.The activity requires 45 hours of individual effort which involves 3 taught sessions followed by a data analysis and interpretation-style assessed exercise. The first taught session covers the ethics and history of clinical testing with emphasis on the problem of bias and the role of Sir Austin Bradford Hill in establishing the randomised clinical trial format. This informs a discussion of clinical trial legislation arising from the findings of the Nuremberg trials which led to the Delcaration of Helsinki, as influenced by the Kefauver-Harris admendments and the Belmont Report. Students are encouraged to consider ethical implications arising in the modern age and also the significance of the 3R’s in minimising use of animals in scientific experimentation. Advanced systematic searching of clinical trial databases is put into practise in a follow-up workshop and a final self-led, mentored IT session provides opportunity to use practise datasets to create forest plots using R-studio and interpret results with reflection on study weighting, heterogeneity and bias containment. Once confident, students embark on an assessed exercise which requires them to apply these skills to test a suitable clinically-themed hypothesis. A proforma-style report is used to record each student’s approach to, i) advanced database searching, ii) eligibility screening of studies using Bradford Hill’s Criteria for Causation, iii) reporting of study triage using the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) protocol, iv) extraction of suitable data, v) creation and interpretation of forest plots, vi) assessment of study heterogeneity by funnel plot and, finally, vii) a comment on physiological causes and mechanisms. A marking rubric enables a weighted grade to be awarded for each element of the process together with feedback to explain the basis of the mark. Through this activity, students utilise their subject-level knowledge in combination with understanding of research ethics, experimental design, bias containment and study power to evaluate questions central to disease causation, drug efficacy and healthcare methods. This provides a useful format for advanced study of clinical questions in the upper years of the undergraduate biomedical curriculum.



Where applicable, experiments conform with Society ethical requirements.

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