Adapting international clinical trials during COVID-19 and beyond

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.

Glucose-6-Phosphate Dehydrogenase (G6PD) Measurement Using Biosensors by Community-Based Village Malaria Workers and Hospital Laboratory Staff in Cambodia: A Quantitative Study

“…Training details have been reported previously [ 18 ]. To avoid larger gatherings during the COVID-19 (coronavirus disease of 2019) pandemic, training sessions were adapted [ 30 ]. VMWs and LTs convened in smaller numbers (5 to 6 per event) for the workshop.…”

Sharing results with participants (and community) in malaria related research: Perspectives and experience from researchers

“…Findings from the SSIs and the survey were summarized into presentation slides and presented to an existing malaria clinical trials network [ 19 ]. The webinar was utilized as a forum for discussion (validity workshop) to assess whether the findings resonated with the participants.…”

“…This mixed-methods study used a sequential exploratory design [18] with two phases [standard annotation: QUAL-QUANT]: i) an initial qualitative phase to explore the topic and to inform the quantitative data collection, ii) a quantitative survey to provide additional context and extrapolate results from the previous phase across a wider audience. This was followed by an informal presentation of preliminary results followed by discussion amongst members within our clinical trial network [19] to validate the findings. removed, it is relatively easy to identify respondents based on their work they talk about, e.g.…”