Implementation of COVID-19 Pandemic Impact Standards

Abstract

COVID-19 pandemic caused emergency situations for clinical trials and there has been a need to assess how COVID-19 pandemic impacts clinical trials. In early 2020, FDA and EMA published Guidance for Industry/Point to Consider document for COVID-19 pandemic impacts for ongoing clinical trials. There was an emergent need to assess COVID-19 pandemic impacts for clinical trials, in particular missed visits assessments and doses. The practical need and ability to conduct remote visits in clinical trials also evolved during the pandemic. We worked together within GSK to Develop and Implement Standards for COVID-19 Pandemic Impacts to comply with CDISC standards and regulatory requirements, to minimize additional sites burden and to implement all studies as timely as possible. As the results, we developed and implemented end-to-end standards for COVID-19 pandemic impacts (eCRF, SDTM/ADaM Datasets, Display Standards). There were couple of revisions after implementation. There are still ongoing discussions and further revision of the standards will be required considering evolving COVID-19 situation, to capture fit-for-purpose data and required per regulatory guidelines. Collaboration of cross functional team and stakeholders were key to implement the changes very quickly and adjust the Standards. We will share what is our standards for COVID-19 pandemic impact and how we collaborated with cross functional team, what we applied from COVID-19 TAUG to develop and how the standards have been evolved.