Mechanistic Ancillary Studies to Ongoing Interventional Clinical Trials (R01)

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This Funding Opportunity Announcement (FOA) solicits applications that propose to conduct time-sensitive mechanistic ancillary studies related to the NIAMS mission in conjunction with privately or publicly funde, ongoing interventional clinical trials. The ongoing parent project has to be an interventional clinical trial that can provide a cohort of well-characterized patients, infrastructure, data, and biological samples. Applications submitted in response to this FOA will undergo an accelerated review and award process. Each application must include a clear description of the ancillary studys mechanistic rationale and premise, and a timeline to demonstrate that the parent project has adequate time left to accommodate the proposed ancillary study. In addition, applicants must justify the time-sensitive nature of the ancillary study and the need for an expedited review and award process. Applicants must also document permission from the parent project to use the patient cohorts, data, and biological materials. The objective of this FOA is to provide a flexible mechanism to leverage established resources and maximize the return on existing investments in parent projects. Successful ancillary studies will enhance the scientific content and value of the parent projects, improve the research communitys understanding of a disease or organ system in the NIAMS portfolio, and thus may identify novel targets for diagnosis, treatment, and prevention of disease.

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