Continuity of care: Perspectives of participants, investigators, and healthcare providers after trial completion in South Africa

Abstract Background Despite decades of updates to frameworks and guidelines for the conduct of clinical trials, what happens to participants when a trial ends remains a persistent ethical dilemma. This study evaluated the views of investigators, healthcare providers (HCPs), and participants regarding post-trial care (PTC) for participants on chronic treatment after trial completion. Method This study involved 38 interviews with 17 investigators, 15 trial participants and six HCPs from 15 trial sites in South Africa. Six of the investigators were also HCPs to the participants, and seven sites were in state or public facilities. Results Post-trial care was unstructured, informal, and not included in trial protocols or budgets. The roles of investigators and HCPs were unclear. Study completion letters intended for HCPs were not received, and investigators arranged follow-up appointments at facilities where they had no ongoing responsibility. Participants continued with their pretrial standard of care (SoC) without the beneficial trial interventions. Discontinuing the intervention mainly affected those with Rheumatoid Arthritis (RA). Without post-trial follow-up (PTFU), the effective implementation of post-trial care for participants is unknown, and no quality of care or stability of treatment could be confirmed after switching treatment and returning to the pre-trial SoC. Investigators and HCPs disputed the concept of post-trial care and supported continuity of care (CoC). CoC was seen as a shared responsibility between investigators and HCPs and dependent on five interrelated processes: first, continued satisfactory quality of care comparable to trial standards at trial exit; second, access to optimal treatment options; third, ensuring effective handover to routine HCPs with adequate information, forth, conducting PTFU ensure stability once participants initiate post-trial care and last, involvement of HCP. Conclusion Our findings propose reframing post-trial care as CoC by expanding the focus beyond the post-trial phase to the entire lifecycle of a trial. By having the trial end in mind, CoC should already be implemented at enrolment and continued until trial conclusion. Recommendations: This study calls on policymakers, sponsors, investigators, and regulators to move beyond a narrow focus on the post-trial phase, primarily aimed at providing access to trial interventions, and adopt a practical, implementable, fundable, and auditable CoC process.