Clinical Trials Grants Program

Clinical Trials Grants Program is sponsored by FDA. Funds clinical trials evaluating efficacy and safety in rare diseases, relevant to rare oncology indications.

Clinical Trials Grants Program | FDA Skip to in this section menu Medical products for rare diseases and conditions Grant Programs to Support Development of Medical Products for Rare Diseases Orphan Products Grants Program Clinical Trials Grants Program Orphan Products Grants Program About the Clinical Trials Grants Program Clinical trial grants for orphan products are a proven method of successfully fostering and encouraging the development of new safe and effective medical products for rare diseases and conditions.

The FDA’s Office of Orphan Products Development (OOPD) administers this program and awards new clinical trial grants annually. Funding for this program is appropriated by Congress. Products that qualify for this grant program are drugs, biologics, medical devices, and foods for medical purposes that are indicated (used) for a disease or condition that affects fewer than 200,000 people in the United States.

Diagnostics and vaccines will qualify for the program only if the U.S. population to whom they will be administered is fewer than 200,000 people per year. Only clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions qualify.

Grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including state and local units of government). Federal agencies may not apply. Of the estimated funding of approximately $17 million per fiscal year, approximately $12 million will fund noncompeting continuation awards, and approximately $5 million will fund new awards, subject to availability of funds.

There are typically 60 to 85 ongoing grant projects every year. OOPD awards approximately 5 to 12 new grants each year, as resources allow. The rapid increase in the cost of clinical trials in recent years has precluded an increase in the number of new grants.

OOPD conducts ongoing grant evaluations to ensure extramural funded studies maintain grant agreement terms and minimize risk to people participating in the clinical research. The FDA is focusing efforts to facilitate and advance new therapies by encouraging innovative clinical trial methods such as adaptive and seamless trial designs, modeling and simulations, and basket and umbrella trials.

The use of shared, established infrastructure and resources and collaborative efforts among stakeholders in industry, academia and patient organizations also facilitates efficient product development. These methods are vital to efficient trials and data evaluation which can expedite drug development.

Additionally, patients living with a rare disease and their caregivers have experiences and knowledge that contribute to important considerations in product development, such as with trial feasibility. For a list of grants awarded under this program, see: Orphan Products Grants Awarded . Resources for applicants and grantees Grants program contact info