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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Article Information
- Received March 17, 2022
- Accepted October 11, 2022
- First Published January 18, 2023.
Author Disclosures
- Daniel G. Di Luca, MD,
- Eric A. Macklin, PhD,
- Karen Hodgeman,
- Gisel Lopez,
- Lindsay Pothier,
- Katherine F. Callahan,
- Jill Lowell,
- James Chan, PhD,
- Aleksandar Videnovic, MD, MSc,
- Codrin Lungu, MD,
- Anthony E. Lang, MD,
- Irene Litvan, MD,
- Michael A. Schwarzschild, MD, PhD and
- Tatyana Simuni, MD, FAAN
- Daniel G. Di Luca, MD,
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- Eric A. Macklin, PhD,
(1) Biogen, (2)Stoparkinson Healthcare, (3) Novartis, (4) Sanofi, (5) Alector, (6) Bial Biotech, (7) Cerevance, (8) Cortexyme, (9) Enterin, (10) InTrance, (11) nQ Medical, (12) Partner Therapeutics, (13) UCB, (14) Chase Therapeutics
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(1) Alector, (2) Amylyx, (3) Biohaven, (4) Calico Life Sciences, (5) Clene Nanomedicine, (6) Mitsubishi Tanabe Pharma America, (7) Prilenia, (8) Revalesio, (9) Seelos, (10) UCB Ra Pharma
(1) NIH/NINDS, U01NS090259, Co-Investigator, 2015-2023,(2) DoD, W81XWH1710121, Statistician, 2017-2023,(3) NIH/NINDS, R01NS102735, Statistician, 2018-2023,(4) NIH/NINDS, U01NS107009, Statistician, 2018-2023,(5) DoD, W81XWH1910184, Co-Investigator, 2019-2023,(6) NIH/NINDS, R01NS110879, Statistician, 2019-2024,(7) NIH/NINDS, U01NS114001, Co-Investigator, 2019-2023,(8) NIH/NCCIH, R01AT010462, Co-Investigator, 2020-2024,(9) NIH/NIA, R01AG047975, Statistician, 2021-2026,(10) NIH/NINR, R01NR019982, Co-Investigator, 2021-2026,(11) NIH/NIA, R21AG067091, Co-Investigator, 2021-2023,(12) NIH/NIA, R01AG075899, Co-Investigator, 2022-2027, (13) DoD, W81XWH2210293, Co-Investigator, 2022-2025, (14) NIH/NIA, R01AG078204, Statistician, 2022-2025,(15) NIH/NIA, R21AG075187, Statistician, 2022-2024
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(1) NIH/NINDS, U01NS090259, Co-Investigator, 2015-2023,(2) DoD, W81XWH1710121, Statistician, 2017-2023,(3) NIH/NINDS, R01NS102735, Statistician, 2018-2023,(4) NIH/NINDS, U01NS107009, Statistician, 2018-2023,(5) DoD, W81XWH1910184, Co-Investigator, 2019-2023,(6) NIH/NINDS, R01NS110879, Statistician, 2019-2024,(7) NIH/NINDS, U01NS114001, Co-Investigator, 2019-2023,(8) NIH/NCCIH, R01AT010462, Co-Investigator, 2020-2024,(9) NIH/NIA, R01AG047975, Statistician, 2021-2026,(10) NIH/NINR, R01NR019982, Co-Investigator, 2021-2026,(11) NIH/NIA, R21AG067091, Co-Investigator, 2021-2023,(12) NIH/NIA, R01AG075899, Co-Investigator, 2022-2027, (13) DoD, W81XWH2210293, Co-Investigator, 2022-2025, (14) NIH/NIA, R01AG078204, Statistician, 2022-2025,(15) NIH/NIA, R21AG075187, Statistician, 2022-2024
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- Karen Hodgeman,
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- Gisel Lopez,
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Non-profit, Funding for travel, MDA (Muscular Dystrophy Association)
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Associate Director Alliance Management, 1 year
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- Lindsay Pothier,
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- Katherine F. Callahan,
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- Jill Lowell,
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- James Chan, PhD,
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- Aleksandar Videnovic, MD, MSc,
Commercial:CoA TherapeuticsAlexion Syneos Health
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Disorders of Sleep and Circadian Rhythms in Parkinson's Disease, Springer, 2015REM Sleep Behavior Disorder, Springer, 2018
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CommercialXW PharmaONO Pharma
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NIH/NINDS, R01 NS099055, PI, 2016-2022:NIH/NINDS, U01 NS114001-01, PI, 2019-2023NIH/NINDS, R21 NS101376-01A1, PI, 2019-2021
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- Codrin Lungu, MD,
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Editorial faculty, Practice Update, from Elsevier, inc. Receiving honoraria since 2014.
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Starting 08/29/2022 employed by Pfizer, inc.
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Starting 08/29/2022, full time employee of Pfizer, inc.
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- Anthony E. Lang, MD,
AbbVie, AFFiRis, Alector, Amylyx, Biogen, BioAdvance, Biohaven, BlueRock, BMS, CoA Therapeutics, Denali, Janssen, Jazz, Lilly, Novartis, Paladin, Retrophin, Roche, Sun Pharma, and UCB
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Sun Pharma, AbbVie, Paladin, and Sunovion
Movement Disorders Clinical PracticeJournal of Neurology, Neurosurgery and PsychiatryAnnals of Neurology
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Schapira A, Lang AE, Fahn S. Movement Disorders 4. Saunders, Elsevier, Philadelphia, PA 2009.Olanow CW, Stocchi F, Lang AE. The Non-motor and Non-Dopaminergic Features of Parkinson’s Disease. Wiley-Blackwell, UK. 2011.Weiner WJ, Shulman LM, Lang AE. Parkinson’s Disease: A Complete Guide for Patients and Families. The Johns Hopkins University Press, Baltimore. 2001Receives publishing royalties from Cambridge University Press.
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Parkinson's UKMSA CoalitionDefeat MSAVan Andel Institute
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Brain Canada,Canadian Institutes of Health ResearchOntario Brain Institute
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Edmond J Safra Philanthropic Foundation, Michael J. Fox Foundation, Parkinson Foundation, Parkinson Canada, W. Garfield Weston FoundationRossy Family Foundation
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- Irene Litvan, MD,
Rossy PSP Center at the University of Toronto
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Chief Editor: Frontiers in Movement Disorders
Levodopameter
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Roche, Abbvie, Biogen, Centogene. EIP-Pharma, Biohaven Pharmaceuticals, Novartis, and United Biopharma SRL - UCB.
National Institutes of Health grants: 2R01AG038791-06A, U01NS090259,U01NS100610, U01NS80818, R25NS098999, P20GM109025; U19 AG063911-1 and 1R21NS114764-01A1
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Michael J Fox Foundation, Parkinson Foundation, Lewy Body Association, CurePSP
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- Michael A. Schwarzschild, MD, PhD and
(1) Michael J. Fox Foundation for Parkinson's Research SAB(New York, NY) [2017-2019](2) Cure Parkinson's Trust foundation Linked Clinical Trialsprogram SAB (London, UK) [~2012- ](3) Corticobasal Degeneration Solutions Foundation SAB(Stockholm, Sweden)(5) Eli Lilly & Company (clinical trial DSMB service); 2018-2021(6) Prevail Therapeutics (clinical advisory board); 2018-2019(7) Parkinson's Foundation (Genetics initiative advisoryboard); 2018-(8) X-linked Dystonia Parkinsonism Clinical Center; 2018-(9) Denali Therapeutics (clinical advisory board); 2019(10) Chase Therapeutics (clinical development advisory board, via PSG); 2019-2020(11) Partner Therapeutics, Inc. (clinical advisory board, via PSG)(12) NIH/NIA-funded TOPAZ trial SC via Sutter Health(13) NIH/NINDS-funded SPARX3 trial SC(14) STEPWISE trial SC via Farmer Family Foundation award(15) Bial Pharmaceuticals (via the Parkinson Study Group)(16) Biogen (via the Parkinson Study Group); 2021 -(17 ) UCB (via the Parkinson Study Group); 2022
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•Denali Therapeutics, seminar speaker (2019)All others are non-profit entities:•Krembil Conference (Toronto) lecture (2019)•World Parkinson Congress, travel/honorarium (2006,2010,2013,2016,2019)•Parkinson Study Group symposium/meeting •for Cure Parkinson's Trust program SAB mtg. (Windsor,UK; Grand Rapids, MI)•for Cure Parkinson's Trust program SAB mtg. (GrandRapids, MI); (travel)
Journal of Adenosine and Caffeine Research, Editorialadvisory board (2018-2020)Parkinsonism and Related Disorders, Editorialadvisory board (2018-)
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Massachusetts General Hospital (sole employer; non-profit)
(1) Harvard University (Parkinson's disease case reviews and epidemiology research); ~2002-present(2) New Beta-Innovations, Inc (Hong Kong); 2016(3) Eli Lilly & Company (clinical trial DSMB service); 2018-2021(4) Prevail Therapeutics, Inc (New York City); 2018-2019(5) Denali Therapeutics (Nice, France); 2019(6) Parkinson Study Group services to nQ Medical (Cambridge, MA; 2019); Chase Therapeutics (Washington, DC; 2019), Partner Therapeutics (virtual; 2020), Bial (virtual; 2021-), Biogen (virtual; 2021-), UCB (virtual; 2022-)
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•NIH R01 NS110879 (PI) 08/01/19 – 05/31/24•NIH U01 NS107009 (a PI) 07/01/18 to 04/30/23•NIH R01NS102735 (Co-Investigator [Xiqun Chen, PI]) 4/1/18 - 3/31/23 •NIH R13 NS111953 (PI) 04/01/19 – 03/31/22•NIH R13 (co-I) 2022-2023•NIH U01 NS090259 (PI) 9/1/2015 to 6/30/2020•NIH R01 (Collaborator [A. Ascherio, PI])
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grant support via my institution (MGH) on projects for which I amthe Principal Investigator:(1) Michael J. Fox Foundation/ASAP(2) Parkinson's Foundation(3) Farmer Family Foundation
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license fee distributions:(1) Adenosine A2A receptor knockout mice, via MGH (which receivespayments from The Jackson Laboratory via licensingagreements); ~2001-present(2) floxed urate oxidase mice, via MGH; 2020-
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- Tatyana Simuni, MD, FAAN
4D Pharma, Acadia, AcureX, AskBio, Amneal, Blue Rock Therapeutics, Caraway Therapeutics, Critical Path for Parkinson's Consortium (CPP), Denali, Michael J Fox Foundation, Neuroderm, Sanofi, Sinopia, Sunovion, Roche, Takeda, UCB, Vanqua Bio and Voyager
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Acadia, Abbvie, Accorda, Adamas, Allergan, Amneal, Anavex, Aptinyx, Blue Rock therapeutics, Denali, General Electric ( GE), Neuroderm, Neurocrine, Sanofi, Sinopia, Sunovion, TEVA, Takeda, Voyager, US World Meds, Parkinson’s Foundation, and the Michael J. Fox Foundation for Parkinson’s Research
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Dr. Simuni has received research funding from Amneal, Biogen, Roche, Neuroderm, Sanofi, Prevail and UCB.
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National Institute of Neurological Disorders and Stroke, Michael J. Fox Foundation, Parkinson’s Foundation.​
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- 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.
- Correspondence
Dr. Schwarzschild michaels{at}helix.mgh.harvard.edu
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