Response of the trial innovation network to the COVID-19 pandemic

Introduction:
The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.

Methods:
The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned.

Results:
The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement.

Conclusions:
Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.

Authors
Greenberg, R., Poole, L., Ford, D., Hanley, D., Selker, H., Lane, K., Dean, J., Burr, J., Harris, P., Wilkins, C., Bernard, G., Edwards, T., Benjamin, D.
Journal
Journal of Clinical and Translational Science
Publication Date
PMCID
PMC8185427
DOI
10.1017/cts.2021.782
Linked Authors
Lori
Poole
Assistant Director Clinical Operations
Daniel E.
Ford, MD, MPH
CTSA PI and Vice Dean for Clinical Investigation
Daniel
Hanley
Professor, Division Director Brain Injury Outcomes, PI JHU-Tufts Trial Innovation Center (NCATS)
Harry
Selker
Dean of Tufts Clinical and Translational Science Institute (CTSI)
Karen
Lane
Assistant Professor, Department of Neurology, Administrative Director, Division of Brain Injury Outcomes
J. Michael
Dean
Associate Dean for Clinical Research
Jeri
Burr
Executive Director
Paul
Harris
Professor of Biomedical Informatics
Consuelo
Wilkins
Executive Director, Meharry Vanderbilt Alliance
Gordon
Bernard
Executive Vice President for Research