Written by:
Erin Brown, Director of Industry Intelligence and Messaging at ACRO
Amid the geopolitical, economic, and regulatory uncertainties of 2025, ACRO worked alongside our members to drive high-quality and innovative clinical research. This year, we have navigated unprecedented turmoil at HHS and the FDA, including a 20 percent reduction in workforce, striking changes to product review procedures, attacks on approved vaccines and on research into the use of mRNA technologies, among other disruptions.
Through it all, ACRO has remained committed to ensuring our members are informed and to continue advocating for a stable and consistent regulatory environment.
From educating federal officials and enhancing data sharing to deepening engagement with global regulators, to providing recommendations on regulatory frameworks for artificial intelligence, data security, and more, we worked to meet the moment and advance the standards of clinical research worldwide.
Engaging With Regulators
In 2025, ACRO hosted seven listening sessions with global regulators on key themes, including application review timelines, the EU Biotech Act, AI/ML, and barriers to EHRs in trials.
- The first-ever ACRO “bilateral” meeting with EMA established that ACRO is an industry stakeholder akin to EFPIA.
- During two listening sessions with MHRA, ACRO leveraged quarterly member surveys and new Agency leadership to help shape the UK regulatory environment.
- Listening sessions with the FDA on AI and RBQM fortified ACRO’s strong relationships with Center experts.
ACRO also submitted 17 written comments to global regulators. A recurring theme in FDA comments has been safeguarding guidance development from the deregulatory agenda, and, in the EU, ACRO has continued to press targeted improvements to the EU Clinical Trial Regulation in its November meeting with the European Commission DG Sante, and written responses to public consultations on the EU Biotech Act.
Educating Policymakers
In 2025, ACRO participated in 59 meetings with policymakers to discuss a wide range of topics, including AI/ML, trial cost, representative clinical trials, trial accessibility, biotechnology, patient retention/recruitment, and the impact of regulatory changes. Through meetings and continued outreach, ACRO has identified seven new Congressional champions. This consistent engagement has facilitated:
- Expanding relationships with Capitol Hill
- Establishing and maintaining contact with Capitol Hill staff and legislators.
- Providing follow-up resources to staff based on topics of discussion.
- Educating legislators by providing expert insight
- Being a reference to staffers and Members of Congress on their areas of interest that are relevant to ACRO’s initiatives.
- Providing suggestions for legislation and oversight opportunities.
- Providing questions for Congressional hearings.
- Learning from Congress
- Learning what Members of Congress are most concerned about and what they may be interested in working on in the future.
- Learning how clinical research and clinical trials impact states and communities.
Deploying Data
In 2025, ACRO conducted several data collection efforts in support of our global and domestic advocacy efforts. Data sharing across members, regulators, and legislators has not only provided much-needed clarity during geopolitical and industry uncertainty, but it has also driven meaningful relationships with global regulators and domestic policymakers.
- 2024 ACRO Member Demographics: In early 2025, ACRO conducted an online survey of its member companies to better understand the activities and demographic makeup of ACRO member organizations and to demonstrate the impact of our industry on drug development. Data from this survey have been used in support of ACRO comment letters, the development of educational resources, and exploration of economic impact.
- RBQM Survey: ACRO’s sixth annual survey of member company CROs evaluates risk-based quality management (RBQM) adoption levels in order to improve our understanding of uptake across the clinical trial industry. This data has consistently deepened collaboration with the FDA through an annual listening session and provides robust data to inform industry discussion through conference panels.
- MHRA Compliance: This quarterly survey evaluates ACRO member experience with MHRA performance to assess delays in clinical trial application review. This data is shared directly with MHRA leadership and UK Department for Business and Trade to shape the regulatory environment.
ACRO Site Resource Grants Program
2025 was the inaugural year of ACRO’s Site Resource Grants Program, a pilot intended to provide resources to clinical trial sites looking to improve representation in and access to clinical trials across the United States. Seven sites participated in the Program throughout the course of 2025, and ACRO will be publishing a white paper in 2026 to share the learnings of the Program.
It has been an unprecedentedly challenging year for our industry. It has never been more critical for ACRO to continue to work alongside our members to advance safe, ethical, high-quality medical research, both domestically and globally, so patients can benefit from the development of new treatments and therapies.
As we navigate 2026, we will continue to commit ourselves to building stability where we can by:
- Educating and engaging with regulators and policymakers in the U.S. and globally to form new relationships and bolster existing ones.
- Providing expert feedback and commentary on proposed regulatory frameworks to ensure the industry perspective is made clear.
- Working with our ACRO committees to drive productive, action-oriented discussions on key issues.
- Conducting our own data collection efforts and analysis to be able to verify current trends and share trusted, unbiased information with our members and beyond.