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

Bauer A., Eskat A., Ntekim A., Wong C., Eberle D., Hedayati E., ...Daha Fazla

JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, cilt.50, sa.4, 2022 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 50 Sayı: 4
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1177/03000605221093179
  • Dergi Adı: JOURNAL OF INTERNATIONAL MEDICAL RESEARCH
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, PASCAL, BIOSIS, CAB Abstracts, EMBASE, Food Science & Technology Abstracts, MEDLINE, Veterinary Science Database, Directory of Open Access Journals
  • Anahtar Kelimeler: COVID-19, pandemic, clinical trial unit, academic research institution, clinical research, research ethics, regulatory authorities, trial management, central trial coordination, rapid review, ETHICS, TRIALS, IMPACT, TIME
  • İstanbul Üniversitesi Adresli: Evet

Özet

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.