Evidence map›Paper›PMID 37555490›Full record

ReviewMultiple sclerosis (Houndmills, Basingstoke, England)2023

Enhancing diversity of clinical trial populations in multiple sclerosis.

Ruth Ann Marrie, Jeremy Chataway, Barbara E Bierer, Marcia Finlayson, Elena H Martinez-Lapiscina, Jennifer Panagoulias, Maria Pia Sormani, Mitzi Joi Williams, Lilyana Amezcua

Open access · hybridAbstract readReview
In one paragraph

Review in Multiple sclerosis (Houndmills, Basingstoke, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
9.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  15. The refined Pathways to Cures Research Roadmap for multiple sclerosis cures.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Article
  16. Article
  17. A tale of race and B cells in multiple sclerosis.Nature reviews. Neurology · 2024
    Article
  18. Article
  19. Enhancing involvement of people with multiple sclerosis in clinical trial design.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 6 countries.

Ruth Ann MarrieDepartments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.ORCID 0000-0002-1855-5595
Jeremy ChatawayQueen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK/National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK/Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.
Barbara E BiererThe Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA/Harvard Medical School, Boston, MA, USA.
Marcia FinlaysonSchool of Rehabilitation Therapy, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.ORCID 0000-0002-1774-4810
Elena H Martinez-LapiscinaCenter of Neuroimmunology, Laboratory of Advanced Imaging in Neuroimmunological Diseases, Hospital Clinic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain/Office of Therapies for Neurological and Psychiatric Disorders, Human Medicines Division, European Medicines Agency, Amsterdam, The Netherlands.
Jennifer PanagouliasFoundation for Angelman Syndrome Therapeutics, Austin, TX, USA.
Maria Pia SormaniDepartment of Health Sciences, University of Genoa, Genoa, Italy.ORCID 0000-0001-6892-104X
Mitzi Joi WilliamsJoi Life Wellness Group MS Center, Atlanta, GA, USA.
Lilyana AmezcuaDepartment of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.ORCID 0000-0003-1542-7819
Brigham and Women's Hospital · USEuropean Medicines Agency · NLNational Institute for Health Research · GBQueen's University · CARome Foundation · USUniversity of Genoa · ITUniversity of Manitoba · CAUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDemographic characteristics, social determinants of health (SDoH), health inequities, and health disparities substantially influence the general and disease-specific health outcomes of people with multiple sclerosis (MS). Participants in clinical trials do not represent all people with MS treated in practice.

objectiveTo provide recommendations for enhancing diversity and inclusion in clinical trials in MS.

methodsWe held an international workshop under the Auspices of the International Advisory Committee on Clinical Trials in MS (the "Committee") to develop recommendations regarding diversity and inclusivity of participants of clinical trials in MS. Workshop attendees included members of the Committee as well as external participants. External participants were selected based on expertise in trials, SDoH, health equity and regulatory science, and diversity with respect to gender, race, ethnicity, and geography.

resultsRecommendations include use of diversity plans, community engagement and education, cultural competency training, biologically justified rather than templated eligibility criteria, adaptive designs that allow broadening of eligibility criteria over the course of a trial, and logistical and practical adjustments to reduce study participant burden. Investigators should report demographic and SDoH characteristics of participants.

conclusionThese recommendations provide sponsors and investigators with methods of improving diversity and inclusivity of clinical trial populations in MS.

Indexed as

Multiple SclerosisClinical Trials as TopicEthnicityHumansResearch DesignSurveys and Questionnairesclinical trialsdiversityMultiple sclerosissocial determinants of health

Identifiers

PMID37555490
PMCPMC10413791
OpenAlexW4385684744

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.