J Surg Surg Educ | Volume 1, Issue 1 | Review Article | Open Access
Eilidh Bruce1*, Tim Rattay2, Lynda Wyld3, Jenna Morgan4, Hilary Stobart5, Sue Hartup6, Baek Kim6, Shelley Potter7, Stuart McIntosh8, Toral Gathani9, Ramsey Cutress10, Rajiv Dave11 and Beatrix Elsberger12
1Department of Breast Surgery, Aberdeen Royal Infirmary, Scotland
2Leicester Cancer Research Centre, University of Leicester, UK
3Department of Oncology and Metabolism, University of Sheffield, Jasmine Breast Centre, Doncaster Royal Infirmary, UK
4NIHR Advanced Fellow in Breast Surgery, University of Sheffield, UK
5Independent Cancer Patients’ Voice, UK
6Department of Breast Oncology, Bexley Wing, St James’s University Hospital, UK
7Department of Oncoplastic Breast Surgery, Translational Health Sciences, Bristol Medical School, UK
8Z Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, UK
9Nuffield Department of Population Health, University of Oxford, UK
10Department of Breast Surgery, Oxford University Hospitals NHS Foundation Trust, UK
11Oncoplastic Breast and Endocrine Surgeon, University Hospital Southampton, Southampton NHS Foundation Trust, UK
12Breast Surgeon, Aberdeen Royal Infirmary, Scotland
*Correspondance to: Eilidh Bruce
Fulltext PDFBackground: National engagement in clinical research benefits the health- service and the wider economy. There has been significant decline in clinical trials enrolment in the UK over the last decade, partly as a result of the coronavirus pandemic and political changes within Europe. The responsibilities associated with the role of Principal Investigator may seem daunting, and accompanied with the pressure of increased clinical workload, this may discourage clinicians from pursuing the role and engaging their local site in a clinical trial. Aims: This review aims to provide a comprehensive summary for local PIs to support their involvement with multi-center trials, optimize participant recruitment and understand the research governance process. Content: Standardized guidance is required to ensure that PIs have the necessary information available to establish clinical trial enrolment, set-up and delivery. Terminology related to running clinical trials is discussed, as well as the advantages and disadvantages of becoming a Principal Investigator. The process to become PI and deliver a trial is discussed in detail, with the following steps: 1. Prepare to become a PI; 2. Select the appropriate clinical trial for your center; 3. Assemble the team; 4. Obtain regulatory research approvals; 5. Oversee protocol delivery and file management; 6. Address protocol amendments; 7. Report on progress and safety. Conclusion: With this guide, clinicians interested in research should understand the attributes of a successful PI, including the necessary research, leadership and management skills, know how to access support, and have a greater understanding of the regulatory landscape in surgical research.
Clinical trials; Principal investigator; Academic surgery
Bruce E, Rattay T, Wyld L, Morgan J, Stobart H, Hartup S, et al. A Step-By- Step Guide to the Role of Principal Investigator in the Setting of Surgical Clinical Trials. J Surg Surg Educ. 2024;1(1):1001..