Penn State Clinical and Translational Science Institute COVID-19 Response: demonstration of how the CTSA program impacts local institution policy and procedures

Abstract

Penn State Clinical and Translational Science Institute has led University-wide efforts to transform clinical and translational science since 2007. It promotes interdisciplinary collaboration and provides essential research infrastructure. This research infrastructure allows Penn State to quickly address and adjust to current events, high priority translational research topics and, most recently, the COVID-19 pandemic. On March 19, 2020, the Governor of Pennsylvania ordered that all non-life sustaining businesses in the state close their physical locations to slow the spread of COVID-19. As of late May 2020, this order to social distance appeared to have "flattened the curve" and limited the death rate from COVID-19 with the most significant mortality seen in the state's southeast corner. This order required significant changes and adjustments to the clinical and research infrastructure, policies and practices of Penn State University and College of Medicine. Penn State Clinical and Translational Science Institute was an integral component of making and implementing these changes. It facilitated cutting-edge research and implemented innovative strategies to address the various complications arising from the COVID-19 pandemic. Among these are:

• Development of contact tracing procedures utilizing REDCap that is currently being used by the PA Department of Health
• Submission of grants and contracts and securing of funding through the consultations and collaboration with central offices at the College of Medicine
• Identification of a site investigator and implementation of both the ACT and ACTIV COVID-19 clinical trials.
• Expansion of PCORNet, TriNetX, ACT data models to include COVID-19 data and participation with the NCATS N3C initiative.
• Development and implementation of the Data4Action Community Project with the Clinical Research Center staff at University Park, serving as the administrative and clinical directors.
• Development of a COVID-19 biorepository in collaboration with Penn State Institute for Personalized Medicine. Penn State Clinical and Translational Science Institute is the honest data broker and developed the biorepository REDCap tracking tool.
• In collaboration with Penn State Health Sports Medicine and the Big Ten, Penn State Clinical and Translational Science Institute coordinating and participating in the Big Ten athletic registry for COVID-19 positive athletes. In addition, the institute, Penn State Heart and Vascular Institute and Department of Radiology, developed several non-invasive protocols to assess cardiac and autonomic function in COVID-19 positive athletes.

These specific examples and many more are demonstrations of how the CTSA program is poised to positively contribute to local institutions as they develop policies, procedures and address current clinical and translational research challenges quickly and efficiently.

Video
Authors
Lawrence
Sinoway
Program Director
CHARITY
SAUDER
Administrative Director, Penn State CTSI
Dee
Bagshaw
Program Manager, CTSI
JENNIFER L
KRASCHNEWSKI
Associate Professor of Medicine, Pediatrics, and Public Health Sciences
Neal
Thomas
Associate Dean for Clinical Research
Matthew
Solovey
Director of Communication, Penn State Clinical and Translational Science Institute