Impact of COVID-19 on Clinical Research Units (CRUs)

Abstract

Few studies have explored the challenges that the COVID-19 pandemic has presented for Clinical Research Units (CRUs), the solutions that have been implemented, and the changes that have been made in the operational guidelines for these entities. This study sought to identify and document common practices implemented by CRUs around the United States of America (USA) when addressing the unique challenges posed by the COVID-19 pandemic. This descriptive study utilized a non-experimental mixed-methods approach and gathered data from representatives of 43 CRUs across the USA. An online survey was followed by in-depth interviews. The findings show that challenges faced from the COVID-19 pandemic, changes made to daily operations, and lessons learned are very similar across CRUs. Although most CRUs never stopped performing essential clinical research, many adapted to the pandemic by engaging in virtual visits, and many played key roles in administering and supporting both COVID-19 therapeutic and vaccine trials. Follow-up interviews showed that processes for formal approval and reopening were similar across CRUs. In addition to highlighting the significance of the role played by CRUs during the COVID-19 pandemic, this study addresses the relevance of CRUs and lays the groundwork for future conversations on the importance of these units.

Conducting clinical genomics research during the COVID‐19 pandemic: Lessons learned from the CSER consortium experience

“…Projects′ experiences raised questions about what research activities do, or should, count as essential. A study of clinical research units across the US reported a general definition of essential research as “research that is essential to a participant′s health and/or well‐being,” (Subramain et al, 2021 ) but the experience of the CSER projects suggests that this definition was not always straightforward to apply in practice, particularly in the setting of a nationwide research consortium. Projects took place in a range of clinical contexts, and recruitment during COVID was affected by changes in which patients were able to attend clinical visits as well as decisions about whether the research itself should continue.…”

Research unit network (RUN) as a learning research system

“…This decision resulted in overlooking these units from any discussion related to translational science. To re-establish dialogue between CRUs that would help units benchmark and improve operations, the Research Unit Network (RUN) was created with the express purpose of enabling direct communication, In addition to facilitating discussions around the topics mentioned already, RUN was pivotal in exchanging information and practices during the beginning of the COVID-19 pandemic [3]. This experience resulted in the identification of the unique roles played by CRUs as part of a disaster response.…”

“…In addition to facilitating discussions around the topics mentioned already, RUN was pivotal in exchanging information and practices during the beginning of the COVID-19 pandemic [3] . This experience resulted in the identification of the unique roles played by CRUs as part of a disaster response.…”

Leadership and administration to advance translational science: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs

“…This included planning and/or implementation of reopening of research activities, primarily for clinical research with lesser involvement for the development and implementation of policies for basic research across all sites. CTSA-supported CRUs played key roles in administering and supporting COVID-19 and vaccine trials [53], including their significant contribution in Phase 3 trials for the Pfizer and Moderna vaccines, the first two vaccines authorized for use in the US.…”