NCATS Clinical Trials

NCATS supports clinical trials and related studies that improve how translation and clinical research are done. The goal is not only to test an intervention, but also to develop better ways to design, start, run, monitor, and complete clinical trials. Projects should help make trials faster, more efficient, more rigorous, and more useful across diseases and settings.

Consistent with NIH modernization efforts and Operation Trialblazer, NCATS is interested in studies that improve trial speed, operational efficiency, data quality, and cost-effectiveness. When making funding decisions, NCATS considers how the proposed work will produce knowledge, tools, or practices that can be used broadly across the clinical research enterprise.

Areas of interest include, but are not limited to:

• New methods, tools, and platforms that improve clinical trial design, start-up, conduct, analysis, and reporting. 
• Approaches to reduce delays in trial activation, contracting, regulatory review, and site readiness. 
• Use of clear performance measures and milestones to track trial progress, support early intervention, and inform go/no-go decisions. 
• Studies that test or improve key trial metrics such as start-up time, enrollment rate, retention, data quality, protocol adherence, and time to results. 
• Use of NIH-supported clinical trial networks and infrastructure, including CTSA-related resources and other collaborative platforms, to improve efficiency and reduce duplication. 
• Reusable playbooks, templates, and standard processes for scientific, clinical, regulatory, manufacturing, and operational activities. 
• Approaches that improve multisite coordination, including use of single IRB models, reliance agreements, and streamlined oversight where appropriate. 
• Trial designs that can move efficiently from highly individualized or small studies to larger early-stage studies when justified. 
• Better use of preclinical evidence, including new approach methodologies such as human cell-based and computational models, to support stronger decisions about what should move into clinical testing. 
• Use of real-world data, electronic health records, claims data, digital health tools, and causal inference methods to improve protocol feasibility, recruitment planning, endpoint collection, and evidence generation. 
• Approaches that improve interoperability and practical use of data from multiple sources. 
• Policies and methods that strengthen rigor in clinical research, including better study design, stronger review readiness, improved data quality, and appropriate safety oversight. 
• Participant-centered approaches, including return of research results when appropriate, to improve trust, engagement, and retention. 
• Decentralized and hybrid trial models that bring research closer to where people live and receive care. 
• Strategies to expand access to clinical research in rural, Tribal, and other underserved communities. 
• Use of telehealth, remote monitoring, digital tools, and community-based care settings to support recruitment, consent, follow-up, and evidence generation while protecting privacy and participant safety. 
• Pragmatic and implementation-focused approaches that improve access, retention, outcomes, and cost-effectiveness. 
• Rare disease studies, especially those that address common barriers in trial design, recruitment, endpoint development, or operations. 
• Basket or umbrella trials that include multiple rare diseases within a single trial. 

NCATS supports clinical trial activities through the end of Phase II for all diseases or conditions. NCATS may also support Phase III clinical trial activities for a rare disease or condition, but only when allowed by the funding announcement and only after all statutory and policy requirements are met under NOT-TR-18-025.

For proposed Phase III activities in a rare disease or condition (as defined here), NCATS must complete additional steps before support can be provided. These steps include public notice, a public comment period of at least 120 days, a determination that no public or private organization has timely plans to conduct a similar trial beyond Phase II, and assurance that Federal liability will not exceed the award value of NCATS support.

NCATS does not intend to invest in routine clinical trial operations that are already widely and commercially available unless there is a clear translational science reason to do so.