Feasibility Studies to Inform the Design of Future Clinical Trials

The National Institutes of Health, within the U.S. Department of Health and Human Services, is preparing to release a funding opportunity focused on feasibility studies that inform the design of future clinical trials. This initiative is associated with the National Center for Complementary and Integrative Health and reflects NIH’s broader mission to advance rigorous biomedical and public health research. The opportunity is currently forecasted, meaning applications are not yet being accepted, but early notice is intended to allow investigators adequate time to prepare collaborations and research concepts aligned with NIH priorities. The primary purpose of this funding opportunity is to support feasibility studies that will directly contribute to the planning and methodological strength of subsequent definitive clinical trials. These future trials may include efficacy, effectiveness, pragmatic, dissemination and implementation, or later-stage phase trials. The feasibility work is expected to address critical uncertainties that could affect trial success, ensuring that future studies are well-designed, scientifically justified, and capable of producing impactful results for public health. Eligible projects may include a wide range of feasibility activities. These can involve testing recruitment strategies, evaluating randomization procedures, assessing participant retention, refining intervention delivery methods, and validating data collection processes. Additional allowable activities include examining adherence, determining acceptability of interventions, and developing or adapting intervention components or study protocols. The program encourages the use of mixed methods and feasibility clinical trials where appropriate, with a strong emphasis on improving rigor and reproducibility in future research. There is no cost-sharing or matching requirement associated with this opportunity, which aligns with NIH’s standard approach for many research grants. While specific funding amounts, award ceilings, and total program funding have not yet been published, applicants should anticipate that detailed budget guidance will be provided in the forthcoming Notice of Funding Opportunity. The funding is categorized under health research, specifically within complementary and integrative health domains. Eligibility for this opportunity is broad and inclusive, encompassing a wide range of organizational types. These include state and local governments, nonprofit organizations with and without 501(c)(3) status, institutions of higher education (both public and private), small businesses, for-profit organizations, tribal governments and organizations, and certain federal and international entities. Faith-based and community-based organizations are also eligible, reflecting NIH’s commitment to diverse participation in research. The submission process is not yet open, but once released, applications will likely follow standard NIH grant submission procedures through Grants.gov and associated systems. Applicants should expect to prepare detailed research plans, justification for feasibility work, and descriptions of how the proposed study will inform a future clinical trial. Evaluation criteria will focus on scientific necessity, methodological rigor, feasibility, and the potential impact of the subsequent trial on public health outcomes. Key timeline estimates indicate that the opportunity is expected to be posted on November 24, 2026, with an estimated application due date of February 16, 2027. Awards are anticipated to be made by December 1, 2027, with project start dates aligned to that timeline. Interested applicants are encouraged to begin planning early, establish collaborations, and monitor NIH communications for the official release of the funding announcement. For inquiries, applicants may contact the NCCIH Division of Extramural Research via email at NCCIHDERFunding@nih.gov.

Focus on demonstrating scientific necessity and how feasibility work strengthens future clinical trials rigor and reproducibility