How COVID-19 changed clinical research strategies: a global survey. Issue 4 (April 2022)

• Record Type: Journal Article
• Authors: Bauer, Annina; Eskat, Anja; Ntekim, Atara; Wong, Creany; Eberle, Deborah; Hedayati, Elham; Tay, Fabian; Yau, Henry; Stockley, Louise; de Medina Redondo, María; Şen, Selçuk; Egert-Schwender, Silvia; Üresin, Yağız; Grossmann, Regina
• Is Part Of: Journal of international medical research. Volume 50:Issue 4(2022)
• Publication Date: 2022-04
• Subjects: COVID-19 -- pandemic -- clinical trial unit -- academic research institution -- clinical research -- research ethics -- regulatory authorities -- trial management -- central trial coordination -- rapid review; Medicine -- Periodicals; Pharmacology -- Periodicals; 610.5
• DOI: 10.1177/03000605221093179
• Languages: English
• ISSNs: 0300-0605

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.