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November 02, 2021; 97 (18) Research Article

Representation of Women in Stroke Clinical Trials

A Review of 281 Trials Involving More Than 500,000 Participants

Cheryl Carcel, Katie Harris, Sanne A.E. Peters, Else Charlotte Sandset, Grace Balicki, Cheryl D. Bushnell, Virginia J. Howard, Mathew J. Reeves, Craig S. Anderson, Peter J. Kelly, Mark Woodward
First published October 13, 2021, DOI: https://doi.org/10.1212/WNL.0000000000012767
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Article Information

vol. 97 no. 18 e1768-e1774
DOI: 
https://doi.org/10.1212/WNL.0000000000012767
PubMed: 
34645708
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received February 14, 2021
  • Accepted in final form August 25, 2021
  • First Published October 13, 2021.

Article Versions

Copyright & Usage: 
© 2021 American Academy of Neurology

Author Disclosures

    1. Cheryl Carcel, MD*,
    2. Katie Harris, PhD*,
    3. Sanne A.E. Peters, PhD,
    4. Else Charlotte Sandset, MD,
    5. Grace Balicki, MIPH,
    6. Cheryl D. Bushnell, MD,
    7. Virginia J. Howard, PhD,
    8. Mathew J. Reeves, PhD,
    9. Craig S. Anderson, MD,
    10. Peter J. Kelly, MD and
    11. Mark Woodward, PhD
  1. Cheryl Carcel, MD*,
    2. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. National Heart Foundation Australia

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Katie Harris, PhD*,
    3. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Sanne A.E. Peters, PhD,
    4. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Else Charlotte Sandset, MD,
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. European Stroke Journal: Editorial Board member, 2016- International Stroke Journal: Editorial Board member 2018- Stroke: Editorial board member, Section Editor, 2020 -

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Grace Balicki, MIPH,
    6. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Cheryl D. Bushnell, MD,
    7. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. Stroke in Women, Henry Stewart Talks, 2007-2020 Neurological Diseases and Pregnancy, Oxford University, 2019- present

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. Patient Centered Outcomes Research Institute PCA-1403- 14532, COMprehensive Post-Acute Stroke Services pragmatic trial; role: co-PI, 3 years Affordability and Efficiency for COMprehensive Post- Acute Stroke Services (COMPASS); AHRQ R01HS025723-01, role: co-PI

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. 1) Care Directions, LLC, No compensation since startup. Stock/Stock Options, Medical Equipment & Materials: Care Directions, LLC; 2020 to present; no financial gain as of 2021

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Virginia J. Howard, PhD,
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. Self: 1) NIH-NINDS, NS41588, co-PI, 2001-present (2) NIH-NIA AG039588, PI, 2011-2020 (3) NIH- NIA P30 AG031054, co-investigator, 2012-present (4) NIH/NINDS NS080165, co-investigator, 2014-present (5) NIH/NIA AG050609, co-investigator, 2016-2021 (6) NIH-NIA AG056360, 2018-present (7) PCORI PCS-2017C3-9081, co-investigator, 2019 to present (8) NIH-NINDS NS097876, co-investigator 2017-present (9) NIH-NIA AG068410, co- investigator 2020-present (10) NIH-NHLBI 1OT2HL158276, co- investigator 2020-present Spouse: Multiple NIH grants.

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Mathew J. Reeves, PhD,
    9. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Circulation- Cardiovascular Quality and Outcomes. Guest Editor 2017-date. Stroke. Technical Editor. 2020-date.

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. Michigan Department of Health and Human Services, Michigan Coverdell Stroke Registry, Consultant, 2012-2021.

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. Craig S. Anderson, MD,
    10. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Receives honoraria and for travel from Takeda China

    Editorial Boards:

    1. Stroke, Cerebrovascular Diseases, International Journal of Stroke, Annals of Neurology, Lancet journals

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Takeda - grant monies paid to my institute for research

    Research Support, Government Entities:

    1. National Health and Medical Research Council (NHMRC) of Australia

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. Peter J. Kelly, MD and
    11. Scientific Advisory Boards:

    1. (1) Alexion (2) Daichii Sankyo

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. Research funding, Health Research Board Ireland

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. The Stroke Clinical Trials Network Ireland has received research support from Pfizer, Amgen, Bristol Myer Squibb, Bayer, Daichii Sankyo, Boehringer

    Research Support, Government Entities:

    1. Prof Kelly has received research grant support from the Health Research Board of Ireland (role: Principal Investigator, Grants CTN-2014-14, DIFA 2017-028, DIFA 2018-006, OLF 2018-1)

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. The Stroke Clinical Trials Network Ireland has received research support from the Irish Heart Foundation, 2016-2020, grant number n/a

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  11. Mark Woodward, PhD
    12. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. (1) Statistics in Medicine, Ass Ed (2) Women's Health, Ed

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Amgen; Kyowa Kirin; Freeline

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. (1) National Health and Medical Research Council (2) NIH (3) European Commission (4) MRFF

    Research Support, Academic Entities:

    1. (1) University of Dundee (2) University of the West Indies

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From The George Institute for Global Health (C.C., K.H., S.A.E.P., G.B., C.S.A., M.W.), University of New South Wales; Sydney School of Public Health (C.C., C.S.A.), Sydney Medical School, The University of Sydney, New South Wales, Australia; The George Institute for Global Health (S.A.E.P., M.W.), Imperial College London, UK; Julius Center for Health Sciences and Primary Care (S.A.E.P.), University Medical Center Utrecht, the Netherlands; Department of Neurology (E.C.S.), Oslo University Hospital; Department of Research and Development (E.C.S.), The Norwegian Air Ambulance Foundation, Oslo, Norway; Department of Neurology (C.D.B.), Wake Forest School of Medicine, Winston-Salem, NC; Department of Epidemiology (V.J.H.), School of Public Health, University of Alabama at Birmingham; Department of Epidemiology and Biostatistics (M.J.R.), Michigan State University, East Lansing; The George Institute China (C.S.A.), Peking University Health Science Center, Beijing; Stroke Service/Department of Neurology (P.J.K.), Mater University Hospital/University College, Dublin, Ireland; and Department of Epidemiology (M.W.), Johns Hopkins University, Baltimore MD.
  1. Correspondence
    Dr. Carcel ccarcel{at}georgeinstitute.org.au
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