Re-engineering the Clinical Research Enterprise in Response to COVID-19: The CTSA Experience

The special issue of the Journal of Clinical and Translational Science, “Re-engineering the Clinical Research Enterprise in Response to COVID-19: The CTSA Experience,” published in June 2021, highlights the Clinical and Translational Science Awards’ (CTSA) tremendous local, regional, and national response to the COVID-19 pandemic. This unique compendium of 14 articles demonstrates the CTSA Program in action, pivoting to address COVID-19’s particular challenge to our nation’s biomedical research enterprise with a multifaceted translational approach. 

As part of the collection, the article "Challenges and Lessons Learned for Institutional Review Board Procedures During the COVID-19 Pandemic" delves into International Review Boards (IRB) meeting the need to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. UCLA CTSI associate director, Dr. Arash Naeim serves as lead author and UCLA CTSI director, Dr. Steven Dubinett, is a co-author. 

As reflected in this collection and in the accompanying Foreword, the CTSA experience during the height of the COVID-19 pandemic exemplifies the collective capacity of the CTSAs as a transformational national network. Among the translational approaches discussed are: the use of telemedicine and remote technologies for patient care and clinical research; adaptation of processes involved with the institutional review board and informed consent; provision of support to clinicians navigating access to COVID-19 therapies; leveraging infrastructure to rapidly create a clinical data repository and biorepositories; engagement with community partners; and reexamination of root causes of health inequities in light of COVID-19. The articles touch upon virtually all the areas of focus of the CTSAs, capturing some of the many ways that the CTSAs have led the way in enhancing the translational process, catalyzing innovation in processes, research tools, and training to meet patient needs. These lessons learned and best practices shared are part of a new clinical and translational research landscape and provide reminders of what the CTSA program has done and can do to continue to address COVID-19 and future public health emergencies.

Explore the special issue here.