Parkinson's Clinical Trial Companion Accelerating Clinical Trials | Page 41

CA SE STUDY NO. 8 Retention Strategies for the Parkinson’s Progression Markers Initiative To complete a study, it is critical to retain study participants. Participant attrition has the potential to interfere with the scientific validity of the study and distort data designed to measure drug efficacy and safety. According to Forte Research: 27 + + Eighty-five percent of clinical trials fail to retain enough participants + + The average dropout rate across all clinical trials is 30 percent Retention is an important element of the Parkinson’s Progression Markers Initiative (PPMI), a landmark, longitudinal, observational study sponsored by The Michael J. Fox Foundation. PPMI (ppmi-info.org) aims to find reliable and consistent biomarkers for Parkinson’s disease (PD) progression by studying cohorts of Parkinson’s patients (de novo idiopathic PD and PD-manifesting genetic mutation carriers), populations at risk for PD (non- manifesting genetic mutation carriers and subjects at risk due to REM sleep behavior disorder or hyposmia) and controls without PD. Participants in PPMI commit to long-term participation, providing biospecimens (e.g., blood, urine, spinal fluid), and undergoing multiple neuroimaging, clinical and behavioral procedures, and assessments over a period of at least five years. The study launched in 2010, and since that time, approximately 1,500 individuals have enrolled. PPMI’s retention rate has consistently held strong, year after year, at about 90 percent. To ensure steady participation and to prevent attrition, PPMI weaves together four key tenets of retention, cultivated and refined since study launch: 1) facilitate participation; 2) communicate study progress; 3) express appreciation; and 4) inform participants of study results. + + Facilitate participation through travel concierge services: PPMI study leadership prioritized and simplified long-term participation in large part because individuals carrying 27 28 specific PD-linked genetic mutations live across a wide geographical area. To facilitate volunteers’ continued participation, PPMI cultivated a boutique experience for them and their care partners. Prospective and enrolled PPMI participants are given the option for complimentary round- trip transportation between their home and appointments at two “super sites” that have the capacity to handle a high volume of study volunteers. A third-party vendor manages all logistical planning, including participants’ accommodations, meals, and travel to and from study visits. This door-to-door service reflects the value PPMI study leadership puts on participation and participants. + + Communicate study progress through newsletters, update calls and a centralized webpage: Reminding participants of the bigger picture is a meaningful way to engage them in the collective success of a study. According to a 2017 report by The Center for Information and Study on Clinical Research Participation, 28 the number one reason individuals choose to participate in clinical research is to help advance science or the treatment of a disease or condition. Given this initial motivation, updates on study progress and contributions to the field will facilitate continued engagement. In PPMI, study progress is communicated in several ways: – – PPMI newsletters provide high-level updates on the study (e.g., study enrollment progress, how the data and samples collected are being used for research) as well as interviews or profiles of study participants and/or study staff. – – PPMI update calls, which are scheduled throughout the year, feature presentations and Q&A sessions with study researchers and study team members. Continued on page 40 https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/ https://www.ciscrp.org/download/2017-perceptions-insights-study-the-participation-experience/?wpdmdl=8770 Chapter Chapter 3 — 4— Building Crafting a Recruitment a Retention Strategy and Toolkit 39