# Wellbeing for staff in UKCRC-registered Clinical Trials Units: Development of the Flourishing As Clinical Trial Staff (FACTS) guidance: a mixed-methods study

## TL;DR

This study develops guidance to improve staff wellbeing in clinical trial units, aiming to enhance job satisfaction and trial efficiency.

## Contribution

The novel contribution is the development of the FACTS guidance with practical strategies to support flourishing among clinical trial staff.

## Key findings

- 67 wellbeing recommendations were developed and refined through focus groups, surveys, and workshops.
- 61 recommendations were endorsed for inclusion in the final guidance to support staff flourishing.
- The guidance is adaptable for use in various research institutions conducting clinical trials.

## Abstract

Evaluating healthcare interventions in clinical trials requires a skilled workforce. However, the demands of developing and running clinical trials make recruiting and retaining staff challenging. Flourishing, which focuses on positive aspects of well-being, may help staff manage these demands. This study introduces the Flourishing As Clinical Trial Staff (FACTS) guidance, offering practical strategies to support staff working in UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs), to thrive at work.

Building upon findings from a national survey of staff working in UKCRC CTUs, a three-phase consensus-based approach was used to develop recommendations to support flourishing in clinical trial staff; (1) focus groups with staff (n = 24), (2) a consensus survey (n = 21) and (3) a consensus workshop (n = 15).

The focus groups identified strategies for supporting CTU staff to flourish, including factors relating to the environment (e.g., flexible working); interpersonal communication (e.g., supportive colleagues), growth (e.g., protected training time) and acknowledgement of everyone's contributions. These strategies were developed into 67 wellbeing recommendations which were further evaluated in a consensus survey and workshop. Following this, 61 recommendations were endorsed for inclusion in the guidance.

The FACTS guidance includes recommendations to support UKCRC CTU staff to flourish in their work and are likely to apply more broadly to research institutions conducting clinical trials. The recommendations provide a foundation for CTUs to review and adapt to their local needs over time. Implementing these recommendations may prove beneficial for increasing job satisfaction and commitment, which is likely to facilitate efficient trial delivery.