VA Lessons From Partnering in COVID-19 Clinical Trials

Area of Science:

• Clinical Trials
• Public Health
• Health Services Research

Background:

• The US Department of Veterans Affairs (VA) Office of Research and Development (ORD) manages a large clinical trials enterprise.
• Historically, external partnerships were limited, but the COVID-19 pandemic highlighted the VA's value due to its extensive healthcare system, diverse patient population, and clinical trial expertise.

Purpose of the Study:

• To describe the VA's experience and lessons learned from participating in large-scale COVID-19 therapeutic and vaccine trials.
• To identify challenges and solutions for conducting multisite clinical studies, especially under pandemic conditions requiring rapid coordination.

Main Methods:

• Leveraging existing VA infrastructure to participate in 7 major COVID-19 trials.
• Developing centralized direction and coordination strategies for multisite studies.
• Documenting challenges and solutions related to site capabilities, study management, education, review processes, study design, contracting, and communication.

Main Results:

• Successful participation in 7 large-scale COVID-19 therapeutic and vaccine trials.
• Gained experience in multisite clinical study practices through external partnerships.
• Identified key areas for improvement in study startup time and overall coordination.

Conclusions:

• VA's participation in COVID-19 trials significantly contributed to research and regulatory approvals.
• Partnerships enhanced external groups' understanding of the VA and provided valuable experience in multisite study conduct.
• These efforts strengthen the VA's capacity to serve the broader scientific and clinical communities.