Objective: To evaluate novel retention strategies in an ongoing phase 3 clinical trial in individuals with Parkinson disease (PD). Adequate participant retention is a significant barrier to the successful completion of phase 3 clinical trials. Length of study, uncertainty of treatment arm and efficacy, treatment side effects, and early participant fatigue contribute to poor retention and dropout leading to ambiguous results.

Background: STEADY-PD III is a 3-year, multicenter, phase 3, placebo-controlled trial of isradipine as a disease-modifying agent in individuals with early-untreated PD. The study enrolled 336 individuals in less than one year.

Methods: Ongoing efforts to enhance retention include weekly emails to the investigator, coordinator and monitors providing study and participant management tips, monthly coordinator conference calls to address retention and trends in protocol violations and data queries; tools and reminders for participants to manage visit schedule and study drug compliance, periodic study participant newsletters to inform participants of ongoing study activities and milestones; participant teleconferences to review study progress and answer participant questions; participant appreciation items to encourage ongoing participation; and travel reimbursement for study participants.

Results: Study recruitment was started in November 2014 and completed in November 2015, 6 months ahead of the schedule. Out of the 336 participants enrolled, to date, 247 (96%) participants remain active in the trial, 13 premature withdrawals, 237 remain active on study drug, and 76 participants completed all study activities. All remaining active participants will complete the study in approximately November 2018.

Conclusions: In this ongoing phase 3, three-year clinical trial, retention has exceeded our initial estimates, likely due in part to our retention efforts. We will continue to employ retention strategies to engage participants and minimize withdrawal in the final year of the study.

« Back to 2018 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/multi-modal-retention-in-a-phase-iii-clinical-trial-in-early-parkinson-disease-steady-pd-iii-2/