The development of an end-to-end service solution to support lupus patients and improve their experience in clinical trials

OBJECTIVE: To develop an end-to-end clinical trial service to improve patient experience during trials, reduce the burden of participating in a trial, and increase trial retention. METHODS: A literature search and stakeholder interviews were used to identify current challenges and unmet needs of systemic lupus erythematosus patients and other systemic lupus erythematosus clinical trial stakeholders. The results from the literature search and interviews were used to create a five-phase map describing the current clinical trial experience of all stakeholders. A set of proposed solutions were developed to address the identified unmet needs and challenges. These solutions were presented to trial-experienced patients and study site personnel; any feedback obtained was used to further refine the solutions. RESULTS: Four site personnel and seven patients from three different systemic lupus erythematosus clinical trial sites were interviewed between September 2015 and December 2015. Key unmet needs and challenges were identified at each stage of the clinical trials. At the screening stage, some patients incorrectly thought they were successfully enrolled into the clinical trial. During enrollment, some patients found it difficult to keep fully informed about the trial and were unable to explain the trial process to loved ones. During the trial, patients struggled to prepare for study visits, felt overwhelmed by the trial process, and wanted someone to talk to for support. Clinical trial site personnel reported current key challenges as: delivering trial information clearly and consistently to patients, setting patient expectations, retaining enrolled patients, and providing non-clinical patient support. To address the needs of patients and site personnel, an end-to-end support service was designed, consisting of nine solutions: My Best Choice, My Eligibility, My Lupus Trial Kit, My Lupus Trial Coach, My Appointment Guide, My Clinic Compass, Our Gratitude, Building a Different Network, and My Next Chapter. CONCLUSION: The solutions proposed in this qualitative study may help improve the systemic lupus erythematosus clinical trial experience for patients, potentially helping to increase trial recruitment and retention. The solutions proposed here would also promote positive patient-trial personnel relationships, which may help site personnel identify patients at risk of early withdrawal, while ensuring that the time and resources of site personnel are used efficiently.