Psychological Experiences of Participants and Staff at the Conclusion of Clinical Trials: A Scoping Review

Psychological experiences reported by participants and staff at trial closure are poorly understood, despite the increased attention to post-trial access to interventions. This scoping review set out to understand the experiences of those involved at the conclusion of clinical trials. Following Joanna Briggs Institute (JBI) methodology, Scopus, Medline and PsycINFO were searched for studies published in the last 30 years. Studies that reported the psychological experiences of either participants or staff after a clinical trial ended were included. Data were extracted using a standardised extraction tool capturing study design, population, trial type, and psychological outcomes, with findings synthesised narratively. Of the nine hundred and thirty-five citations identified, eleven studies met the inclusion criteria and were included in the review. Negative psychological experiences were widely reported among participants on completion of clinical trials. Key themes included anxiety, fear of loss, feelings of abandonment and emotional attachment to trial interventions when transferring back to previous care settings. Participants from low-resourced settings were particularly vulnerable due to the lack of healthcare availability when the trial concluded. Only three studies reported the psychological experiences of staff and those reported negative emotions and conflicts between research obligations and participant welfare. The end of the trial period is a significant psychological event for both a participant and staff, yet current ethical frameworks provide limited explicit guidance regarding psychological support and transition planning during this time. Our findings suggest that post-trial psychological support and structured transition planning should be embedded within clinical trial protocols and ethics review processes.