Hosted by AMRC, this timely webinar offered insights into the evolving federal policy and funding landscape affecting multisite clinical research corporations (MCRCs), with a strong focus on strategic advocacy and the challenges ahead.
Speakers Patrick Cooney, President, The Federal Group, and Jim Kremidas, Executive Director, AMRC, focused on how government funding changes could impact clinical trials in a number of areas, and what MCRCs can do in these uncertain times.
Key Takeaways
- Executive Orders Are Limited:
While executive orders may make headlines, they are temporary in that they can be changed by the next president. Real lasting change comes through legislation and regulatory reform. The courts are now engaged with determining the constitutional authority of many of these executive orders so stay tuned. - Congressional Gridlock and Budget Drama:
With razor-thin margins in Congress, the executive branch will struggle to advance its agenda through legislation. Opportunity exists in regulatory relief. What changes would benefit clinical research? Budget debates and spending decisions for fiscal year 2026 are taking shape so now is a good time to be educating your members of Congress about what you value in federal spending (i.e. clinical research) and how it impacts the community. - Spending vs. Saving:
Although funding exists for the remainder of fiscal year 2025, the debate is now about how—or whether—it gets spent. The Administration is trying to cut spending along ideological lines since legislative avenues are more difficult. This has already resulted in significant grant terminations, especially around vaccine research. - Advocacy Is Essential:
The most effective way to protect research funding is through targeted, grassroots advocacy. Constituents—individuals, companies, and research organizations—are encouraged to build relationships with their elected officials and their key health care staff. - Funding Cuts and Staffing Strains:
Cuts at NIH and other HHS departments are contributing to low morale and attrition. The federal courts have ruled on several executive orders to reinstate staff. However, appropriate staffing will be an ongoing issue for federal agencies and the Congress to determine. Regulatory flexibility remains a key area where the FDA can help accelerate access to clinical trials and new therapies. Staff at the FDA are somewhat protected given the user fees from industry which fund much of their work. - Equity and DEI Under Threat:
DEI initiatives are being defunded across the federal government relating to workforce, but some areas of health care equity appear to be impacted as well. Without active advocacy, areas like cancer research, reproductive health, rare genetic diseases, and COVID-related research risk further funding cuts. - Opportunities for Education and Advocacy:
Both speakers emphasized AMRC’s important role in educating lawmakers and Administration officials on the benefits of research and established science, including vaccine development and diversity in clinical trials. - Looking Ahead:
The upcoming budget debate for fiscal year 2026 and beyond will reveal more about which areas may benefit or suffer. Chronic disease is a topic of growing interest, and there’s cautious optimism that some equity-focused funding may remain intact due to congressional support. MCRCs must stay informed and engaged to shape outcomes.