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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, View ORCID ProfileGrace Balicki, Cheryl D. Bushnell, View ORCID ProfileVirginia 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
Cheryl Carcel
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.
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Katie Harris
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.
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Sanne A.E. Peters
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.
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Else Charlotte Sandset
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.
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Grace Balicki
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.
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  • ORCID record for Grace Balicki
Cheryl D. Bushnell
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.
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Virginia J. Howard
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.
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Mathew J. Reeves
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.
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Craig S. Anderson
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.
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Peter J. Kelly
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.
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Mark Woodward
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.
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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
Neurology Nov 2021, 97 (18) e1768-e1774; DOI: 10.1212/WNL.0000000000012767

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Abstract

Background and Objectives Women have been underrepresented in cardiovascular disease clinical trials but there is less certainty over the level of disparity specifically in stroke. We examined the participation of women in trials according to stroke prevalence in the population.

Methods Published randomized controlled trials with ≥100 participants enrolled between 1990 and 2020 were identified from ClinicalTrials.gov. To quantify sex disparities in enrollment, we calculated the participation to prevalence ratio (PPR), defined as the percentage of women participating in a trial vs the prevalence of women in the disease population.

Results There were 281 stroke trials eligible for analyses with a total of 588,887 participants, of whom 37.4% were women. Overall, women were represented at a lower proportion relative to their prevalence in the underlying population (mean PPR 0.84; 95% confidence interval [CI] 0.81–0.87). The greatest differences were observed in trials of intracerebral hemorrhage (PPR 0.73; 95% CI 0.71–0.74), trials with a mean age of participants <70 years (PPR 0.81; 95% CI 0.78–0.84), nonacute interventions (PPR 0.80; 95% CI 0.76–0.84), and rehabilitation trials (PPR 0.77; 95% CI 0.71–0.83). These findings did not significantly change over the period from 1990 to 2020 (p for trend = 0.201).

Discussion Women are disproportionately underrepresented in stroke trials relative to the burden of disease in the population. Clear guidance and effective implementation strategies are required to improve the inclusion of women and thus broader knowledge of the impact of interventions in clinical trials.

Glossary

CI=
confidence interval;
GBD=
Global Burden of Disease;
ICH=
intracerebral hemorrhage;
PPR=
participation to prevalence ratio;
SSWM=
sample size weighted mean

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • ↵* These authors contributed equally to this work.

  • Received February 14, 2021.
  • Accepted in final form August 25, 2021.
  • © 2021 American Academy of Neurology
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