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

Author:

Bauer Annina1ORCID,Eskat Anja2,Ntekim Atara3,Wong Creany4,Eberle Deborah5,Hedayati Elham6,Tay Fabian7,Yau Henry8,Stockley Louise9,de Medina Redondo María7,Şen Selçuk8,Egert-Schwender Silvia9,Üresin Yağız10,Grossmann Regina11

Affiliation:

1. Annina Bauer Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland

2. Anja Eskat Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland

3. Atara Ntekim University of Ibadan/University College Hospital Ibadan, Ibadan, Nigeria

4. Creany Wong Clinical Trials Centre, The University of Hong Kong, Hong Kong

5. Deborah Eberle Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland

6. Elham Hedayat Department of Oncology-Pathology, Cancer Center Karolinska, Karolinska Institute, Stockholm, Sweden

7. Fabian Tay Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland

8. Henry Yau Clinical Trials Centre, The University of Hong Kong, Hong Kong

9. Louise Stockley Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

10. María de Medina Redondo Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland

11. Selçuk Şen Center of Excellence for Clinical Research, University of Istanbul, Istanbul, Turkey

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.

Publisher

SAGE Publications

Subject

Biochemistry (medical),Cell Biology,Biochemistry,General Medicine

Reference36 articles.

1. World Health Organization. Guidance for managing ethical issues in infectious disease [Internet]. 2016 [cited 2021 Aug 16]. Available from: https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf?sequence=1&isAllowed=y

2. World Health Organization. International Clinical Trials Registry Platform (ICTRP) [Internet]. [cited 2021 Sep 6]. Available from: https://www.who.int/clinical-trials-registry-platform

3. WHO–Solidarity [Internet]. WHO COVID-19 Solidarity Therapeutics Trial. 2022 [cited 2022 Feb 28]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments

4. COVID-19 Ethics and Research

5. Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19

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