How COVID-19 changed clinical research strategies: a global survey.
de Medina Redondo, María
J Int Med Res
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Bauer, A., Eskat, A., Ntekim, A., Wong, C., Eberle, D., Hedayati, E., Tay, F., et al. (2022). How COVID-19 changed clinical research strategies: a global survey.. J Int Med Res, 50 (4) https://doi.org/10.1177/03000605221093179
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.
Prospective Clinical Research Report, COVID-19, pandemic, clinical trial unit, academic research institution, clinical research, research ethics, regulatory authorities, trial management, central trial coordination, rapid review
External DOI: https://doi.org/10.1177/03000605221093179
This record's URL: https://www.repository.cam.ac.uk/handle/1810/336565