Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To evaluate novel retention strategies in an ongoing phase 3 clinical trial in individuals with Parkinson disease (PD)
Background: 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, and early participant fatigue contribute to poor retention and drop out leading to ambiguous results. We aim to mitigate these barriers with a novel multimodal retention strategy in an attempt to minimize participant withdrawals..
Methods: STEADY-PD III is a multicenter NINDS funded 36 month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10mg daily versus placebo on slowing progression of PD disability in 336 participants with early PD. The study was powered for a maximum of 5% per year participant attrition. The efforts to mitigate retention barriers include: selection of highly qualified sites, monthly investigator and coordinator conference calls to address retention issues; periodic study participant newsletters to inform participants of ongoing study activities and milestones; a planned participant teleconference to review study progress and address participant questions; retention appreciation gifts to encourage ongoing participation; and travel reimbursement for study participants.
Results: All participants have completed their one year follow up in November 2016, and the last participant is expected to complete the study in November 2018. Out of the 336 participants enrolled, 330 (98%) remain active in the study.
Conclusions: In this ongoing phase 3 clinical trial, retention has exceeded our initial estimates. We will continue to monitor retention to engage participants and minimizes participant withdrawal.
References: Study supported by the NINDS U01NS080818 and U01NS080840
To cite this abstract in AMA style:
B. Greco, T. Simuni, J. Denmark, S. Henderson, J. Lowell, S. Sharma, C. Tarolli, D. Young, K. Biglan. Multi-modal retention in a phase III clinical trial in early Parkinson disease (STEADY-PD III) [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/multi-modal-retention-in-a-phase-iii-clinical-trial-in-early-parkinson-disease-steady-pd-iii/. Accessed June 14, 2025.« Back to 2017 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/