How COVID-19 changed clinical research strategies: a global survey.

Change log
Eskat, Anja 
Ntekim, Atara 
Wong, Creany 
Eberle, Deborah 

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.

COVID-19, academic research institution, central trial coordination, clinical research, clinical trial unit, pandemic, rapid review, regulatory authorities, research ethics, trial management, Adaptation, Psychological, COVID-19, Cross-Sectional Studies, Humans, Pandemics, Surveys and Questionnaires
Journal Title
J Int Med Res
Conference Name
Journal ISSN
Volume Title
SAGE Publications