Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials

doi:10.1212/CPJ.0000000000200113

. 2023 Feb;13(1):e200113.

doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18.

Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials

Affiliations

Affiliation

¹ Edmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.

PMID: 36865634
PMCID: PMC9973288
DOI: 10.1212/CPJ.0000000000200113

Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials

Daniel G Di Luca et al. Neurol Clin Pract. 2023 Feb.

. 2023 Feb;13(1):e200113.

doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18.

Affiliation

¹ Edmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.

PMID: 36865634
PMCID: PMC9973288
DOI: 10.1212/CPJ.0000000000200113

Abstract

Background and objectives: Representation of persons from marginalized racial and ethnic groups in Parkinson disease (PD) trials has been low, limiting the generalizability of therapeutic options for individuals with PD. Two large phase 3 randomized clinical trials sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), STEADY-PD III and SURE-PD3, screened participants from overlapping Parkinson Study Group clinical sites under similar eligibility criteria but differed in participation by underrepresented minorities. The goal of this research is to compare recruitment strategies of PD participants belonging to marginalized racial and ethnic groups.

Methods: A total of 998 participants with identified race and ethnicity consented to STEADY-PD III and SURE-PD3 from 86 clinical sites. Demographics, clinical trial characteristics, and recruitment strategies were compared. NINDS imposed a minority recruitment mandate on STEADY-PD III but not SURE-PD3.

Results: Ten percent of participants who consented to STEADY-PD III self-identified as belonging to marginalized racial and ethnic groups compared to 6.5% in SURE-PD3 (difference = 3.9%, 95% confidence interval [CI] 0.4%-7.5%, p value = 0.034). This difference persisted after screening (10.1% of patients in STEADY-PD III vs 5.4% in SURE-PD 3, difference = 4.7%, 95% CI 0.6%-8.8%, p value = 0.038).

Discussion: Although both trials targeted similar participants, STEADY-PD III was able to consent and recruit a higher percentage of patients from racial and ethnic marginalized groups. Possible reasons include differential incentives for achieving minority recruitment goals.

Trial registration information: This study used data from The Safety, Tolerability, and Efficacy Assessment of Isradipine for Parkinson Disease (STEADY-PD III; NCT02168842) and the Study of Urate Elevation in Parkinson's Disease (SURE-PD3; NCT02642393).

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References

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1. Picillo M, Kou N, Barone P, Fasano A. Recruitment strategies and patient selection in clinical trials for Parkinson's disease: going viral and keeping science and ethics at the highest standards. Parkinsonism Relat Disord. 2015;21(9):1041-1048. doi:10.1016/j.parkreldis.2015.07.018. - DOI - PubMed
1. Burke JF, Brown DL, Lisabeth LD, Sanchez BN, Morgenstern LB. Enrollment of women and minorities in NINDS trials. Neurology. 2011;76(4):354-360. doi:10.1212/wnl.0b013e3182088260. - DOI - PMC - PubMed

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[1] Van Den Eeden SK, Tanner CM, Bernstein AL, et al. . Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003;157(11):1015-1022. doi:10.1093/aje/kwg068. - DOI - PubMed

[2] Van Den Eeden SK, Tanner CM, Bernstein AL, et al. . Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003;157(11):1015-1022. doi:10.1093/aje/kwg068. - DOI - PubMed

[3] Zhang ZX, Roman GC. Worldwide occurrence of Parkinson's disease: an updated review. Neuroepidemiology. 1993;12(4):195-208. doi:10.1159/000110318. - DOI - PubMed

[4] Zhang ZX, Roman GC. Worldwide occurrence of Parkinson's disease: an updated review. Neuroepidemiology. 1993;12(4):195-208. doi:10.1159/000110318. - DOI - PubMed

[5] de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006;5(6):525-535. doi:10.1016/s1474-4422(06)70471-9. - DOI - PubMed

[6] de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006;5(6):525-535. doi:10.1016/s1474-4422(06)70471-9. - DOI - PubMed

[7] Picillo M, Kou N, Barone P, Fasano A. Recruitment strategies and patient selection in clinical trials for Parkinson's disease: going viral and keeping science and ethics at the highest standards. Parkinsonism Relat Disord. 2015;21(9):1041-1048. doi:10.1016/j.parkreldis.2015.07.018. - DOI - PubMed

[8] Picillo M, Kou N, Barone P, Fasano A. Recruitment strategies and patient selection in clinical trials for Parkinson's disease: going viral and keeping science and ethics at the highest standards. Parkinsonism Relat Disord. 2015;21(9):1041-1048. doi:10.1016/j.parkreldis.2015.07.018. - DOI - PubMed

[9] Burke JF, Brown DL, Lisabeth LD, Sanchez BN, Morgenstern LB. Enrollment of women and minorities in NINDS trials. Neurology. 2011;76(4):354-360. doi:10.1212/wnl.0b013e3182088260. - DOI - PMC - PubMed

[10] Burke JF, Brown DL, Lisabeth LD, Sanchez BN, Morgenstern LB. Enrollment of women and minorities in NINDS trials. Neurology. 2011;76(4):354-360. doi:10.1212/wnl.0b013e3182088260. - DOI - PMC - PubMed

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Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials

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Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials

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Associated data

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