Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management

Abstract

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n ¼ 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre-and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation.

Health professionals' views about who would benefit from using a closed‐loop system: a qualitative study

“…These findings suggest that regular, ongoing reviews of individuals using closed‐loop systems will be essential, in line with recommendations for those using other diabetes technologies . Even if clear guidance is put in place for when to remove a closed‐loop system, this may still be a very challenging task , and effective team working may be vital .…”

Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

“…Many cited a need for on-going monitoring of trial participants for some time following trial exit. The same concern has been expressed by several other authors (Lawton et al (2019), and Bukenya, Seeley, Tumwekwase, Kabunga, and Ruzagira (2020)) who demonstrate that additional follow up and support of HIV positive clients following linkage to care significantly improved their general outcomes. The need to compensate trial participants for their engagement in research was another issue raised in the current study, .…”

“…The copyright holder for this this version posted November 16, 2020. ; https://doi.org/10.1101/2020.11.14.20231720 doi: medRxiv preprint 1 1 important to reduce negative emotional effects associated with trial closure (Lawton et al, 2019), and to offer guidance to participants on the next steps in accessing HIV care.…”

“…The copyright holder for this this version posted November 16, 2020. ; https://doi.org/10.1101/2020.11.14.20231720 doi: medRxiv preprint 3 trial closure (Cho et al, 2018). Additionally, the need for monitoring and compensation for potential adverse effects from trial interventions (Lawton et al, 2019), and provision of trial feedback (Chen et al, 2016;Schroter, Price, Malički, Richards, & Clarke, 2019), have been key concerns in post-trial (research) ethics.…”

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation

“…Participants eagerly awaited their appointments with the dietitian, and the cessation of the intervention at 18 weeks shocked and saddened them, as they felt a keen sense of loss. These psychological and emotional effects on participants at the conclusion of trials have been reported in a number of other qualitative articles examining postintervention transition to usual care, with participants reporting a sense of loss, disappointment, anxiety, and isolation [32,33]. This highlights the need to incorporate how to manage the psychological impacts of abrupt cessation of intensive interventions on trial participants in the future [33].…”