Objective: To review a successful multi-modal recruitment strategy in a clinical trial of early untreated PD patients.

Background: 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 the progression of PD disability in 336 participants with early PD. Traditionally, recruitment of this early PD population has been challenging.

Methods: Prior to initiating recruitment, we developed a comprehensive recruitment strategy including 1) development of a Recruitment Committee of relevant stake holders including principal investigators, project managers, patient advocates, representatives from the sites, the Michael J. Fox Foundation (MJFF), and NINDS; 2) Early and consistent involvement of advocacy organizations in recruitment efforts, including the Parkinson’s disease Foundation, MJFF, the National Parkinson Foundation, and the Muhammad Ali Foundation; 3) Presence at local, national and international meetings and patient events; 4) Recruitment tools including a toll-free number to connect patients with a study site, dedicated study website and email address, Fox Trial Finder, advocacy training webinars, study specific printed recruitment brochures, posters, and newsletters; 5) National and local press releases; 6) Monthly coordinator teleconference calls to review and modify recruitment strategies; 7) Targeted minority recruitment strategies including additional funding of selected sites; and 8) Involvement in the NIH sub-study RECRUIT to increase the racial/ethnic diversity of study participants.

Results: A total of 413 patients were screened with 336 participants including 34 minority subjects enrolled between November 3, 2014 and October 28, 2015. This was 6 months ahead of schedule with over 20 potential participants on reserve. Referral sources included: Site personnel (n= 222), Neurologist (n=99), Fox Trial Finder (n=42), MJFF communication (n=16), Website or Web Ad (n= 10), Self (n=9), Primary Care Physician (n=3), Family or friend (n=3), Event (n = 3), Specialist (n=2), other (n=4).

Conclusions: A multi-modal recruitment approach involving relevant stake holders can expedite enrollment in PD clinical trials and has implications for future research studies.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/multi-modal-recruitment-strategy-leads-to-expeditious-enrollment-in-steady-pd-iii/