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.
| Original language | English |
|---|---|
| Pages (from-to) | 237-241 |
| Number of pages | 5 |
| Journal | Clinical Trials |
| Volume | 20 |
| Issue number | 3 |
| Early online date | 11 Feb 2023 |
| DOIs | |
| Publication status | Published - Jun 2023 |
Bibliographical note
Funding Information: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 SIRIN studies (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 (NCT 04411836) 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).
Publisher Copyright:
© The Author(s) 2023.
