An Evidence Based Methodological Framework for Pandemic Preparedness to Support the Clinical Trial Unit Workforce

Aims: : This study reports a new workforce preparedness framework for use during pandemics, specifically within clinical trials units. Methods: An evidence-based framework was developed using qualitative and quantitative data, as reported by the EPIC observational study. A framework methodology was used to analyse qualitative and quantitative data to identify themes. The themes were used to identify sub-themes that were codes with illustrative quotes. A logic model was develop using spatial features. Results: The qualitative component of the study included the views of 6 semi-structured interviews where discussions indicated the need for flexible working, requirement for better operational management, and access to electronic data systems remotely. Conclusion: Significant mental health impact on the CTU workforce can be prevented by the introduction of a framework to streamline operational delivery of research, providing flexible working patterns to the workforce, and improved access to health and wellbeing practices. Funding calls should be made available to conduct further workforce-based research in the UK and to develop evidence-based policies to better prepare for future pandemics.