Adapting international clinical trials during COVID-19 and beyond
Issued Date
2023-01-01
Resource Type
ISSN
17407745
eISSN
17407753
Scopus ID
2-s2.0-85148073182
Pubmed ID
36772825
Journal Title
Clinical Trials
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical Trials (2023)
Suggested Citation
Thriemer K., Degaga T.S., Alam M.S., Adhikari B., Tripura R., Hossain M.S., Christian M., Ghanchi N.K., Mnjala H., Weston S., Ley B., Rumaseb A., Tadesse D., Teferi T., Yilma D., Lee G., Unger H., Sutanto I., Pasaribu A.P., Ghimire P., Beg M.A., Price R.N. Adapting international clinical trials during COVID-19 and beyond. Clinical Trials (2023). doi:10.1177/17407745231154215 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/82230
Title
Adapting international clinical trials during COVID-19 and beyond
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Oxford University Clinical Research Unit
Arba Minch University
Tribhuvan University
Jimma University
Universitas Sumatera Utara
Universitas Indonesia
The Aga Khan University
Menzies School of Health Research
International Centre for Diarrhoeal Disease Research Bangladesh
Nuffield Department of Medicine
Arba Minch Institute of Technology
Oxford University Clinical Research Unit
Arba Minch University
Tribhuvan University
Jimma University
Universitas Sumatera Utara
Universitas Indonesia
The Aga Khan University
Menzies School of Health Research
International Centre for Diarrhoeal Disease Research Bangladesh
Nuffield Department of Medicine
Arba Minch Institute of Technology
Other Contributor(s)
Abstract
Background: The COVID-19 pandemic and resulting restrictions, particularly travel restrictions, have had significant impact on the conduct of global clinical trials. Our clinical trials programme, which relied on in-person visits for training, monitoring and capacity building across nine low- and middle-income countries, had to adapt to those unprecedented operational challenges. We report the adaptation of our working model with a focus on the operational areas of training, monitoring and cross-site collaboration. The new working model: Adaptations include changing training strategies from in-person site visits with three or four team members to a multi-pronged virtual approach, with generic online training for good clinical practice, the development of a library of study-specific training videos, and interactive virtual training sessions, including practical laboratory-focused training sessions. We also report changes from in-person monitoring to remote monitoring as well as the development of a more localized network of clinical trial monitors to support hybrid models with in-person and remote monitoring depending on identified risks at each site. We established a virtual network across different trial and study sites with the objective to further build capacity for good clinical practice–compliant antimalarial trials and foster cross-country and cross-study site collaboration. Conclusion: The forced adaptation of these new strategies has come with advantages that we did not envisage initially. This includes improved, more frequent engagement through the established network with opportunities for increased south-to-south support and a substantially reduced carbon footprint and budget savings. Our new approach is challenging for study sites with limited prior experience but this can be overcome with hybrid models. Capacity building for laboratory-based work remains difficult using a virtual environment. The changes to our working model are likely to last, even after the end of the pandemic, providing a more sustainable and equitable approach to our research.