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

AimsThis study reports a new workforce preparedness framework for use during pandemics, specifically within clinical trials units. MethodsAn 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. ResultsThe 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. ConclusionSignificant 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. O_TEXTBOXWhat is already known?O_LIEpidemic preparedness data indicate many countries remain unprepared C_LIO_LIThere are large gaps in knowledge and practice base for continuity of research conduct during a lock-down circumstances C_LIO_LIGeneric pandemic preparedness frameworks were available although these had limited relevance to Higher Education Institutions (HEIs) and National Health Services (NHS) that conduct significant volumes of clinical research studies C_LI What are the new findings?O_LIEpidemic Preparedness Index (EPI) that uses a ranking approach in 188 countries have been developed. The EPI includes health capacities and capabilities, including non-healthcare system features C_LIO_LIThe use of EPI scores to correlate with proxy measure for preparedness including detection, investigation and reporting of any outbreaks as well as vaccination rates. Examples include the UK flue vaccination rates and the 2009 H1N1 influenza pandemic C_LIO_LICapacity to detect and respond to epidemics and pandemic appear to be weak across a number of global regions including Asia and Africa despite the higher risk of emergence of pathogens C_LIO_LIImpact of a pandemic on the healthcare and clinical research workforce is significant. There are many limitations in terms of the support available to manage their own wellbeing C_LIO_LIDifferent levels of complexities exist globally in terms of research regulations and legislations which impact the efficiency of setting up and conducting a study C_LIO_LIThe impact of the pandemic to clinical trial unit staff in the UK indicated a number of aspects that need to be improved pertinent at an organisational and individual level C_LI What do the new findings imply?O_LIHealthcare and Academic institutions as well as the internal units require fit-for-purpose preparedness procedures C_LIO_LIImproved risk planning and mitigation frameworks would be required to better understand and develop methods to continue to deliver work C_LI C_TEXTBOX