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dc.contributor.authorBauer, Annina
dc.contributor.authorEskat, Anja
dc.contributor.authorNtekim, Atara
dc.contributor.authorWong, Creany
dc.contributor.authorEberle, Deborah
dc.contributor.authorHedayati, Elham
dc.contributor.authorTay, Fabian
dc.contributor.authorYau, Henry
dc.contributor.authorStockley, Louise
dc.contributor.authorde Medina Redondo, María
dc.contributor.authorŞen, Selçuk
dc.contributor.authorEgert-Schwender, Silvia
dc.contributor.authorÜresin, Yağız
dc.contributor.authorGrossmann, Regina
dc.date.accessioned2022-05-28T08:00:11Z
dc.date.available2022-05-28T08:00:11Z
dc.date.issued2022-04
dc.identifier.issn0300-0605
dc.identifier.other35469473
dc.identifier.otherPMC9087250
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/337588
dc.description.abstractOBJECTIVE: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics. METHODS: We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies. RESULTS: All 19 participating academic research institutions developed and followed similar strategies, including preventive measures, manpower recruitment, and prioritisation of COVID-19 projects. In contrast, measures for centralised management or coordination of COVID-19 projects, project preselection, and funding were handled differently amongst institutions. Regulatory bodies responded similarly to the pandemic by implementing fast-track authorisation procedures for COVID-19 projects and developing guidance documents. Quality and consistency of the information and advice provided was rated differently amongst institutions. CONCLUSION: Both academic research institutions and regulatory bodies worldwide were able to cope with challenges during the COVID-19 pandemic by developing similar strategies. We identified some unique approaches to ensure fast and efficient responses to a pandemic. Ethical concerns should be addressed in any new decision-making process.
dc.languageeng
dc.publisherSAGE Publications
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.sourcenlmid: 0346411
dc.sourceessn: 1473-2300
dc.subjectClinical research
dc.subjectPandemic
dc.subjectResearch Ethics
dc.subjectRegulatory Authorities
dc.subjectRapid Review
dc.subjectTrial Management
dc.subjectClinical Trial Unit
dc.subjectCovid-19
dc.subjectAcademic Research Institution
dc.subjectCentral Trial Coordination
dc.subjectHumans
dc.subjectCross-Sectional Studies
dc.subjectAdaptation, Psychological
dc.subjectPandemics
dc.subjectSurveys and Questionnaires
dc.subjectCOVID-19
dc.titleHow COVID-19 changed clinical research strategies: a global survey.
dc.typeArticle
dc.date.updated2022-05-28T08:00:08Z
prism.issueIdentifier4
prism.publicationNameJ Int Med Res
prism.volume50
dc.identifier.doi10.17863/CAM.84997
dcterms.dateAccepted2022-03-23
rioxxterms.versionofrecord10.1177/03000605221093179
rioxxterms.versionVoR
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.contributor.orcidBauer, Annina [0000-0002-5379-7418]
dc.identifier.eissn1473-2300
cam.issuedOnline2022-04-25


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Attribution-NonCommercial 4.0 International
Except where otherwise noted, this item's licence is described as Attribution-NonCommercial 4.0 International