The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

Abstract

Introduction: The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19. Methods: Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020 Results: Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies. Conclusion: This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic

Impact of the COVID-19 pandemic on CTSA Clinical Research Centers over 2 years

“…The great majority of CRCs responding to our survey participated in COVID-related research efforts, including vaccine trials, noninterventional studies (e.g., biorepositories, serology studies, and diagnostic development), and therapeutic trials. CRC support spanned the spectrum of clinical research activities, including study start-up, regulatory support, training of clinical research staff, and conduct of study visits, confirming earlier reports [ 5 , 11 ]. Participation in noninterventional studies was higher than in therapeutic trials, likely representing lower staffing barriers to conducting noninterventional studies.…”

“…Reasons for this included continued safety concerns from participants and investigators and staffing shortages. Many CRCs reported that they mitigated the negative impact on research activities by pivoting to support COVID-related research, maintaining close coordination with institutional entities and investigators, implementing practices to mitigate risks to research personnel, and adopting innovative approaches to supporting clinical research during the pandemic, including eConsent, virtual visits, electronic source documentation, and home delivery of experimental therapeutic agents [1][2][3][4][9][10][11]. These latter approaches allowed outpatient clinical research to resume, but most would not be captured as CRC census.…”

“…Our survey results underscore many of these findings, highlighting the value of a robust patient-oriented clinical research infrastructure that can rapidly respond to evolving events by reducing nonessential research activities, pivoting to innovative methods that allow clinical research to proceed in a virtual environment, and deploying CRCs’ considerable resources to support pandemic-related research [ 16 ]. Previous publications have highlighted the additional role that CRCs and CTSA Hubs can play in prioritizing clinical research studies for enrollment of patients into COVID-related trials, utilizing fair and transparent criteria that include direct benefit to patients, avoidance of competition for enrollment, protection of providers, efficient use of limited resources, health disparities, and access to care [ 1 , 11 , 16 ].…”

Developing adaptive capacity and preparedness in clinical and translational science

“…Our colleagues from the New Jersey Alliance for Clinical and Translational Science (NJ ACTS) [4] contribute to a better understanding of regulatory mechanisms during an emergency by identifying and comparing metrics illustrating the efficiency and efficacy of their research mobilization efforts during COVID-19. Their analysis of data from the Institutional Review Board, the Clinical Research Units, and the Office of Research and Sponsored Programs suggests that by rapidly making process improvements and adaptations, their institution effectively responded to challenges posed by the pandemic, including a significant increase in IRB-approved studies in 2020, the enrollment of adult and pediatric participants for COVID-19-related research, study income, and decrease in turnaround time for approval of COVID-19 studies.…”