Adapting international clinical trials during COVID-19 and beyond

K Thriemer; TS Degaga; MS Alam; B Adhikari; R Tripura; MS Hossain; M Christian; NK Ghanchi; H Mnjala; S Weston; B Ley; A Rumaseb; D Tadesse; T Teferi; D Yilma; G Lee; H Unger; I Sutanto; AP Pasaribu; P Ghimire; MA Beg; RN Price

Journal article

Adapting international clinical trials during COVID-19 and beyond

K Thriemer, TS Degaga, MS Alam, B Adhikari, R Tripura, MS Hossain, M Christian, NK Ghanchi, H Mnjala, S Weston, B Ley, A Rumaseb, D Tadesse, T Teferi, D Yilma, G Lee, H Unger, I Sutanto, AP Pasaribu, P Ghimire Show all

Clinical Trials | Published : 2023

DOI: 10.1177/17407745231154215

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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 generi..

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University of Melbourne Researchers

Holger Unger Author

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Funding Acknowledgements

The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: Funding for this work was provided by the Australian Academy of Science, on behalf of the Department of Industry, Innovation and Science. The Regional Collaborations Programme COVID-19 Digital Grant is supported by the Australian Government under the National Innovation and Science Agenda. The PRIMA and SIR INstudies (NCT 03916003 and 04079621) are co-funded by a grant from the Australian Academy of Science Regional Collaborations Programme, the Bill & Melinda Gates Foundation (grant no. OPP1164105/INV-010504) and the National Health and Medical Research Council (NHMRC)(grant no. GNT1132975). The EFFORT study (NCT04411836) is funded through NHMRC (grant no.APP1182950) and the Bill & Melinda Gates Foundation (grant no. INV-024389). The SAPOT study (NCT 05426434) is funded through the NHMRC (grant no. APP2000780).