Adaptive trials in stroke: Current use & future directions
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Le résumé fourni par la source
Abstract Inclusion of adaptive design features in a clinical trial provides pre-planned flexibility to dynamically modify a trial during its conduct, while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology as compared to traditional fixed designs. Stroke is a natural candidate for adoption of these innovative approaches to trial design. This Research Methods in Neurology paper is informed by scoping review that identified 45 completed and ongoing adaptive clinical trials in stroke that were appraised: 14 trials had published results with or without a published protocol, 15 trials had a published protocol, and 16 trials were registered only. Treatments spanned acute (n=28), rehabilitation (n=8), prevention (n=8), and rehabilitation and prevention (n=1) domains. A subsample of these trials were selected to illustrate the utility of adaptive design features and discuss why each adaptive feature(s) were incorporated in the design to best achieve the aim, whether each individual feature was used and if it resulted in expected efficiencies, and any learnings during preparation, conduct or reporting. We then discuss the operational, ethical, and regulatory considerations that warrant careful consideration during adaptive trial planning and reflect on the workforce readiness to deliver adaptive trials in practice. We conclude that adaptive trials can be designed, funded, conducted, and published for a wide range of research questions and offer future directions to support adoption of adaptive trial designs in stroke and neurological research more broadly.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Adaptive trials in stroke: Current use & future directions
- Date Crossref
- 05/04/2024
- Éditeur
- openRxiv
- Type
- posted-content
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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The University of Melbourne Melbourne Medical School pays non établi dans la noticeUniversité ou école supérieure
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Florey Institute of Neuroscience and Mental Health pays non établi dans la noticeStructure de recherche
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Melbourne Health pays non établi dans la noticeÉtablissement de santé
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National Health and Medical Research Council pays non établi dans la noticeOrganisme public
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The Royal Melbourne Hospital pays non établi dans la noticeOrganisme public
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University of Cincinnati Department of Neurology and Rehabilitation Medicine pays non établi dans la noticeUniversité ou école supérieure
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Allen Institute for Brain Science pays non établi dans la noticeStructure de recherche
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University of Calgary Department of Clinical Neuroscience and Hotchkiss Brain Institute pays non établi dans la noticeUniversité ou école supérieure
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Luther University Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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Martin Luther University Halle-Wittenberg pays non établi dans la noticeUniversité ou école supérieure
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Saarland University Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
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University of Ottawa Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
Melbourne Medical School — The University of Melbourne, Florey Institute of Neuroscience and Mental Health et Melbourne Health, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.