2026 Policy Priorities and Solutions - Flipbook - Page 13
A National Life Sciences Strategy
To secure long-term US leadership in biomedical innovation, we support the establishment of a National Life Sciences
Strategy and Implementation Plan. Such a strategy provides a unified national vision that aligns scientific opportunity,
population health needs, and economic competitiveness; sets priorities for emerging technologies; and strengthens
coordination across the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease
Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), and other agencies, as well as the
private and philanthropic sectors. A national coordinator for life sciences strategy within the Department of Health and
Human Services (HHS) would help ensure agencies move in alignment with strategic priorities and adapt to scientific
and technological change.
Data as Infrastructure for Biomedical Innovation
Unlocking the next era of biomedical progress requires treating data as essential national infrastructure. High-quality,
interoperable, and patient-empowered data systems are foundational to accelerating discovery, improving clinical
evidence, and expanding access to innovation. We support establishing national data-quality standards, modernizing
federal platforms, and building a federated data ecosystem that securely links the strengths of CDC, NIH, FDA, and
CMS. Public–private “data missions” can bring together diverse datasets to address urgent health challenges, while
expanded tools, such as the Trusted Exchange Framework and Common Agreement for research and patient-controlled
data wallets, can ensure individuals meaningfully shape how their information drives progress. By investing in a modern,
connected, and patient-centered data infrastructure, the US can position its health ecosystem to achieve faster
breakthroughs, stronger evidence generation, and broader access to lifesaving innovations.
Innovation and Access to Clinical Trials
Clinical trials in the US must expand patient participation and address inefficiencies that hinder sponsors, sites, and the
nation’s capacity to run trials at scale. Just as we need a national life sciences strategy and shared data infrastructure,
we need a national agenda for clinical trials, informed by a public–private partnership that brings together government,
industry, academia, health systems, and patient groups. The US must invest in national clinical trial infrastructure,
beginning with the establishment of an Office of the National Clinical Trial and Research Coordinator within HHS to
coordinate efforts across federal agencies to improve the efficiency and effectiveness of clinical trials, and to build a
national clinical trial and research network inventory. We must make it easier for patients and clinicians to participate
in clinical trials by broadening eligibility criteria, simplifying informed consent, and clarifying reimbursement policies for
trial participation. And we must reduce the administrative burden of conducting clinical trials by clarifying overlapping
regulatory requirements, expanding use of single institutional review boards and reliance agreements, standardizing
contracts and liability frameworks, clarifying FDA’s Form 1572 to ease unnecessary documentation burdens, and
simplifying Medicare coverage analysis to alleviate the burden on sites seeking to run trials.
Strong Federal Health Agencies
To respond effectively to scientific and technological advances, federal health agencies must continuously evolve to
keep pace with scientific knowledge. We support strengthening the CDC as a critical federal agency to advance the
population health of the nation. As a global leader for biomedical research, the NIH should be reinforced as the nation’s
engine for bold, cross-cutting biomedical research and transformative science through interdisciplinary collaboration.
Finally, we support a strong FDA with a focus on regulatory science that continues to advance its public health mission
to enable safety and efficacy of new innovations to achieve better health outcomes.
MILKEN INSTITUTE
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