Literature DB >> 33150545

Overcoming Barriers to Parkinson Disease Trial Participation: Increasing Diversity and Novel Designs for Recruitment and Retention.

Pavan A Vaswani1, Thomas F Tropea1, Nabila Dahodwala2.   

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.

Entities:  

Keywords:  Clinical trial; Parkinson disease; barriers; diversity; recruitment; trial design

Mesh:

Year:  2020        PMID: 33150545      PMCID: PMC7851248          DOI: 10.1007/s13311-020-00960-0

Source DB:  PubMed          Journal:  Neurotherapeutics        ISSN: 1878-7479            Impact factor:   6.088


  41 in total

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3.  Implications of Eligibility Criteria on the Generalizability of Alcohol and Drug Treatment Outcome Research: A Study of Real-World Treatment Seekers in Sweden and in Australia.

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4.  Patient Eligibility for Randomized Controlled Trials in Critical Care Medicine: An International Two-Center Observational Study.

Authors:  Ryan M J Ivie; Emily A Vail; Hannah Wunsch; Monica P Goldklang; Robert Fowler; Vivek K Moitra
Journal:  Crit Care Med       Date:  2017-02       Impact factor: 7.598

5.  Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a "Pure" Patient Phenotype and the Generalizability of Trial Findings.

Authors:  Hitesh C Patel; Carl Hayward; Jason N Dungu; Sofia Papadopoulou; Abdel Saidmeerasah; Robin Ray; Carlo Di Mario; Nesan Shanmugam; Martin R Cowie; Lisa J Anderson
Journal:  J Card Fail       Date:  2017-04-18       Impact factor: 5.712

Review 6.  The prevalence of Parkinson's disease: a systematic review and meta-analysis.

Authors:  Tamara Pringsheim; Nathalie Jette; Alexandra Frolkis; Thomas D L Steeves
Journal:  Mov Disord       Date:  2014-06-28       Impact factor: 10.338

7.  Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement.

Authors:  Edward S Kim; Suanna S Bruinooge; Samantha Roberts; Gwynn Ison; Nancy U Lin; Lia Gore; Thomas S Uldrick; Stuart M Lichtman; Nancy Roach; Julia A Beaver; Rajeshwari Sridhara; Paul J Hesketh; Andrea M Denicoff; Elizabeth Garrett-Mayer; Eric Rubin; Pratik Multani; Tatiana M Prowell; Caroline Schenkel; Marina Kozak; Jeff Allen; Ellen Sigal; Richard L Schilsky
Journal:  J Clin Oncol       Date:  2017-10-02       Impact factor: 44.544

Review 8.  Representation of the elderly, women, and minorities in heart failure clinical trials.

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Journal:  Arch Intern Med       Date:  2002 Aug 12-26

9.  Patients enrolled in large randomized clinical trials of antiplatelet treatment for prevention after transient ischemic attack or ischemic stroke are not representative of patients in clinical practice: the Netherlands Stroke Survey.

Authors:  Lisette Maasland; Robert J van Oostenbrugge; Cees F Franke; Wilma J M Scholte Op Reimer; Peter J Koudstaal; Diederik W J Dippel
Journal:  Stroke       Date:  2009-06-25       Impact factor: 7.914

10.  Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion.

Authors:  Carlen Reyes; Anton Pottegård; Peter Schwarz; M Kassim Javaid; Tjeerd P Van Staa; Cyrus Cooper; Adolfo Diez-Perez; Bo Abrahamsen; Daniel Prieto-Alhambra
Journal:  Calcif Tissue Int       Date:  2016-04-20       Impact factor: 4.333

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Review 2.  Moving the Dial Toward Equity in Parkinson's Disease Clinical Research: a Review of Current Literature and Future Directions in Diversifying PD Clinical Trial Participation.

Authors:  Jennifer Adrissi; Jori Fleisher
Journal:  Curr Neurol Neurosci Rep       Date:  2022-06-17       Impact factor: 6.030

Review 3.  Opportunities and challenges of alpha-synuclein as a potential biomarker for Parkinson's disease and other synucleinopathies.

Authors:  Pedro Magalhães; Hilal A Lashuel
Journal:  NPJ Parkinsons Dis       Date:  2022-07-22

Review 4.  Moving Forward from the COVID-19 Pandemic: Needed Changes in Movement Disorders Care and Research.

Authors:  B Y Valdovinos; J S Modica; R B Schneider
Journal:  Curr Neurol Neurosci Rep       Date:  2022-02-02       Impact factor: 6.030

  4 in total

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