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Adapting International Clinical Trials During Covid-19 And Beyond, Kamala Thriemer, Kamala Thriemer, Mohammad Shafiul Alam, Bipin Adhikari, Rupam Tripura, Mohammad Sharif Hossain, Michael Christian, Najia Bano Ghanchi, Hellen Mnjala, Muhammad Asim

Department of Pathology and Laboratory Medicine

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 …