What is the study about?

The FACTS study team are working with clinical trial staff and other academics to develop guidance for Clinical Trials Units (CTUs) in order to help them improve employee workplace wellbeing (flourishing). Flourishing encompasses interpersonal factors, including the role of workplace social interactions and intrapersonal factors, encompassing the interplay of the energy and value obtained from the working environment. Although the role of flourishing in clinical trial staff has yet to be directly investigated, there is evidence to suggest these factors are related to job satisfaction and staff turnover in clinical trial staff as well as trial efficiency. Flourishing could ensure staff continuity and subsequently, consistency in protocol delivery, site management, participant recruitment etc.

The study aim is to understand the role of flourishing and job satisfaction in clinical trial unit (CTU) staff and develop guidance on how to support staff to flourish. Understanding the role of staff flourishing in CTUs will enable the development and implementation of workplace wellbeing models that support staff to flourish; promoting job satisfaction and equipping staff with the personal resources required to work efficiently in their conduct of high-quality clinical research.

What have we done?

We conducted surveys with staff at all UKCRC-registered CTUs (n=484), focus groups (n=24) and consensus panels (n=18) to understand levels of wellbeing, develop solutions, explore implementation issues and reach an agreement on support strategies. 

Guidance Development

From this work, we developed the FACTS guidance which provides recommendations to CTUs on how to support staff wellbeing to promote job satisfaction and commitment. The guidance aims to support CTU staff to flourish from within, at an individual level, and create a flourishing social environment within their CTUs. Workplace flourishing is associated with higher job satisfaction and commitment, therefore, implementing the FACTS guidance will support CTUs’ operational capability and efficiency in conducting high quality clinical research.

In 2024, the FACTS study team received the UKCRC CTU Directors' award for the presentation with greatest impact at the International Clinical Trials' Methodology Conference. Since this conference, the team have received national and international interest in implementing the guidance.

Dissemination and Evaluation

The FACTS guidance is the first step in addressing a significant gap in current wellbeing support for employees working in clinical research institutions. 

We are currently in the process of circulating the FACTS guidance to all UKCRC-registered CTUs. We will be monitoring the implementation and impact of the guidance through a pre-implementation survey and a six-month follow-up survey.

Thank you

Developing the FACTS guidance would not have been possible without the help of the study participants and those who provided detailed input on the content and format of this guidance through a consensus development process – thank you!

Funder

National Institute for Health and Care Research (NIHR) - Efficient Studies Funding (ESF)

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