VA Lessons From Partnering in COVID-19 Clinical Trials

Abstract and Introduction

Abstract

Background: The US Department of Veterans Affairs (VA) Office of Research and Development (ORD) supports an extensive clinical trials enterprise. Until recently, external partnerships were limited. The VA’s potential value as a partner became more apparent during the COVID-19 pandemic because of its large health care system, diverse patient population, and expertise in conducting clinical trials.

Observations: By leveraging its infrastructure, the VA was able to participate in 7 large-scale COVID-19 therapeutic and vaccine trials. A key aspect of this enterprise approach is the ability to provide centralized direction and coordination. The VA’s partnerships with external groups offered insights into the challenges associated with conducting important trials, especially when rapidity and coordination were essential. The ORD also developed solutions for reducing study startup time that could be established as best practices. We offer lessons for the challenges VA faced: site infrastructure needs and capabilities; study management roles and responsibilities; educational resources; local review; study design demands; contracting and budgeting; central-level systems; and communication.

Conclusions: VA participation in major COVID-19 therapeutic and vaccine trials represented a significant part of its research response to the pandemic. These contributions extended beyond the participants, scientists, and data that helped inform subsequent regulatory approvals. The VA also had an opportunity to directly develop partnerships with non-VA groups. These groups became more familiar with the VA while enabling us to gain more experience in the diverse practices used to conduct multisite clinical studies. Ultimately, these efforts empower the VA to further serve the broader scientific and clinical communities.

Introduction

The US Department of Veterans Affairs (VA), through its Office of Research and Development (ORD), supports an extensive and experienced clinical research enterprise, including the first multisite trials in the US.^[1] These resources contribute to the ORD support for the largest US integrated health care system, with a primary focus on the care and well-being of veterans. While the history of VA research has facilitated the creation of an experienced and organized research enterprise, the COVID-19 pandemic challenged VA to contribute even more significantly. These challenges became pronounced given the urgency associated with standing up VA sites for both therapeutic and vaccine trials.

Cite this: VA Lessons From Partnering in COVID-19 Clinical Trials - Medscape - Nov 22, 2023.

Table COVID-19 Clinical Trials With VA Centralized Support
Trial sponsor/name	Trial type	VA sites, No.	Support resource(s)
Pharma/other agency	Vaccine	17	PRP, NODES
Pharma/other agency V	Vaccine	2	PRP, NODES
VA ORD/VA CURES-1	Therapeutic	23	CURES
Other agency/ACTIV-2	Therapeutic	8	VA ICC
Other agency/ACTIV-3	Therapeutic	24	VA ICC
Other agency/ACTIV-4a	Therapeutic	9	CURES
Other agency/STRIVE	Therapeutic	21	VA ICC

Abbreviations: ACTIV, Accelerating COVID-19 Therapeutic Interventions and Vaccination; CURES, Coronavirus Research and Efficacy Studies; ICC, International Coordinating Center; NODES, Network of Dedicated Enrollment Sites; ORD, Office of Research and Development; PRP, Partnered Research Program; STRIVE, Strategies and Treatments for Respiratory and Infections and Viral Emergencies; VA, US Department of Veterans Affairs.