Forecast for Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
This grant will fund research to improve clinical trial readiness for rare diseases by developing tools like biomarkers and outcome measures to help move new treatments or diagnostics toward successful trials.
Funder: National Institutes of Health (NIH)
Due Dates: February 18, 2026 | June 17, 2026 | February 17, 2027 | June 17, 2027 | February 17, 2028 | June 20, 2028
Funding Amounts: Up to $275,000 direct costs over 2 years; no more than $200,000 in any single year; max project period is 2 years.
Summary: Supports research to enhance clinical trial readiness in rare diseases by validating biomarkers, clinical outcome assessments, or defining disease natural history.
Key Information: Clinical trials are not allowed; focus is on preparatory research for future clinical trials in rare diseases.
Description
This NIH opportunity invites applications for clinical research projects that address critical needs for clinical trial readiness in rare diseases, disorders, and syndromes. The goal is to facilitate the transition of candidate therapeutics or diagnostics toward clinical trials and increase their likelihood of success. Supported activities include the development and validation of biomarkers and clinical outcome assessment measures, or studies defining the presentation and course of rare diseases to inform clinical trial design. Projects must not propose clinical trials themselves, but rather focus on preparatory work essential to enable future trials.
