How COVID-19 changed clinical research strategies: a global survey.
dc.contributor.author | Bauer, Annina | |
dc.contributor.author | Eskat, Anja | |
dc.contributor.author | Ntekim, Atara | |
dc.contributor.author | Wong, Creany | |
dc.contributor.author | Eberle, Deborah | |
dc.contributor.author | Hedayati, Elham | |
dc.contributor.author | Tay, Fabian | |
dc.contributor.author | Yau, Henry | |
dc.contributor.author | Stockley, Louise | |
dc.contributor.author | de Medina Redondo, María | |
dc.contributor.author | Şen, Selçuk | |
dc.contributor.author | Egert-Schwender, Silvia | |
dc.contributor.author | Üresin, Yağız | |
dc.contributor.author | Grossmann, Regina | |
dc.date.accessioned | 2022-05-28T08:00:11Z | |
dc.date.available | 2022-05-28T08:00:11Z | |
dc.date.issued | 2022-04 | |
dc.identifier.issn | 0300-0605 | |
dc.identifier.other | 35469473 | |
dc.identifier.other | PMC9087250 | |
dc.identifier.uri | https://www.repository.cam.ac.uk/handle/1810/337588 | |
dc.description.abstract | OBJECTIVE: 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.language | eng | |
dc.publisher | SAGE Publications | |
dc.rights | Attribution-NonCommercial 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0/ | |
dc.source | nlmid: 0346411 | |
dc.source | essn: 1473-2300 | |
dc.subject | Clinical research | |
dc.subject | Pandemic | |
dc.subject | Research Ethics | |
dc.subject | Regulatory Authorities | |
dc.subject | Rapid Review | |
dc.subject | Trial Management | |
dc.subject | Clinical Trial Unit | |
dc.subject | Covid-19 | |
dc.subject | Academic Research Institution | |
dc.subject | Central Trial Coordination | |
dc.subject | Humans | |
dc.subject | Cross-Sectional Studies | |
dc.subject | Adaptation, Psychological | |
dc.subject | Pandemics | |
dc.subject | Surveys and Questionnaires | |
dc.subject | COVID-19 | |
dc.title | How COVID-19 changed clinical research strategies: a global survey. | |
dc.type | Article | |
dc.date.updated | 2022-05-28T08:00:08Z | |
prism.issueIdentifier | 4 | |
prism.publicationName | J Int Med Res | |
prism.volume | 50 | |
dc.identifier.doi | 10.17863/CAM.84997 | |
dcterms.dateAccepted | 2022-03-23 | |
rioxxterms.versionofrecord | 10.1177/03000605221093179 | |
rioxxterms.version | VoR | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc/4.0/ | |
dc.contributor.orcid | Bauer, Annina [0000-0002-5379-7418] | |
dc.identifier.eissn | 1473-2300 | |
cam.issuedOnline | 2022-04-25 |
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