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

Journal

Neurology. Clinical practice
ISSN: 2163-0402
Titre abrégé: Neurol Clin Pract
Pays: United States
ID NLM: 101577149

Informations de publication

Date de publication:
Feb 2023
Historique:
received: 17 03 2022
accepted: 11 10 2022
entrez: 3 3 2023
pubmed: 4 3 2023
medline: 4 3 2023
Statut: ppublish

Résumé

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. 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. 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%, 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. 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).

Sections du résumé

Background and Objectives UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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%,
Discussion UNASSIGNED
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 UNASSIGNED
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).

Identifiants

DOI: 10.1212/CPJ.0000000000200113 PMID: 36865634 PMC: PMC9973288
pubmed: 36865634
doi: 10.1212/CPJ.0000000000200113
pii: CPJ-2022-200111
pmc: PMC9973288
doi:

Banques de données

ClinicalTrials.gov
['NCT02168842', 'NCT02642393']

Types de publication

Journal Article

Langues

eng

Pagination

e200113

Subventions

Organisme : NINDS NIH HHS
ID : U01 NS090259
Pays : United States

Informations de copyright

Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

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Auteurs

Daniel G Di Luca (DG)

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.
ORCID: 0000-0002-1356-4919

Eric A Macklin (EA)

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.
ORCID: 0000-0003-1618-3502

Karen Hodgeman (K)

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.

Gisel Lopez (G)

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.

Lindsay Pothier (L)

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.

Katherine F Callahan (KF)

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.

Jill Lowell (J)

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.

James Chan (J)

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.

Aleksandar Videnovic (A)

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.

Codrin Lungu (C)

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.

Anthony E Lang (AE)

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.

Irene Litvan (I)

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.
ORCID: 0000-0002-3485-3445

Michael A Schwarzschild (MA)

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.

Tatyana Simuni (T)

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.

Classifications MeSH