Overcoming Barriers to Parkinson Disease Trial Participation: Increasing Diversity and Novel Designs for Recruitment and
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REVIEW
Overcoming Barriers to Parkinson Disease Trial Participation: Increasing Diversity and Novel Designs for Recruitment and Retention Pavan A. Vaswani 1 & Thomas F. Tropea 1 & Nabila Dahodwala 1 Accepted: 22 October 2020 # The American Society for Experimental NeuroTherapeutics, Inc. 2020
Abstract Parkinson disease (PD) is highly prevalent among neurodegenerative diseases, affecting a diverse patient population. Despite a general willingness of patients to participate in clinical trials, only a subset of patients enroll in them. Understanding the barriers to trial participation will help to alleviate this discrepancy and improve trial participation. Underrepresented minorities, older patients, and patients with more medical comorbidities in particular are underrepresented in research. In clinical trials, this has the effect of delaying trial completion, exacerbating disparities, and limiting our ability to generalize study results. Efforts to improve trial design and recruitment are necessary to ensure study enrollment reflects the diversity of patients with PD. At the trial design level, broadening inclusion criteria, attending to participant burden, and focusing on trial efficiency may help. At the recruitment stage, increasing awareness, with traditional outreach or digital approaches; improving engagement, particularly with community physicians; and developing targeted recruitment efforts can also help improve enrollment of underrepresented patient groups. The use of technology, for virtual visits, technology-based objective measures, and community engagement, can also reduce participant burden and increase recruitment. By designing trials to consider these barriers to trial participation, we can improve not only the access to research for all our patients but also the quality and generalizability of clinical research in PD. Keywords Clinical trial . recruitment . barriers . Parkinson disease . trial design . diversity
Introduction Parkinson disease (PD) is the second most common neurodegenerative disease, affecting patients in a range of ages, geographic locations, and racial and ethnic backgrounds, and affecting men and women [1–3]. There is a pressing need for both basic science and clinical research to develop improved therapeutics. However, poor recruitment is a chronic problem in clinical studies of patients with PD. An informal survey by The Michael J. Fox Foundation (MJFF) found that although 80% of patients were at least “somewhat likely” to be willing to participate in a trial, fewer than 10% had participated [4]. Patients who do participate in a trial overwhelmingly report a willingness to enroll in another and would recommend participation to others [5]. Despite this readiness of patients, 90% of * Nabila Dahodwala [email protected] 1
Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA
clinical trials fail to enroll patients within the target amount of time requiring an extended enrollment period [6]. Furthermore, only 1/3 of multicenter trials achieve t
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