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ANCILLARY STUDIES IN CLINICAL TRIALS (R01): RFA-HL-12-012

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Components of Participating Organizations

National Heart, Lung, and Blood Institute

Application Receipt Date(s): May 27, 2011; September 27, 2011; January 27, 2012

Clinical trials and large observational cohorts represent a substantial research investment, and are unique sources of well-characterized patient populations. They are not, however, usually structured to permit a detailed investigation of underlying mechanisms of the disease and its progression. For example, identifying surrogate markers is crucial for predicting which patients are at high risk and for designing treatments that can be tailored and targeted to patients with specific characteristics. Such investigations often are best conducted as ancillary studies, and thus require supplementary funding. The FOA program described in this initiative has provided a flexible, cost-effective, and administratively efficient mechanism to facilitate the use of existing large patient cohorts for the study of disease processes and outcomes, genetics and proteomics, therapeutic response, quality of life, behavioral and lifestyle issues, treatment adherence, and health economics. Overall, a relatively modest investment in time-sensitive ancillary studies can result in significant scientific gains in translational and clinical research without incurring the substantial cost of recruiting a new cohort, and can lead to improved diagnostic and prognostic assessments and patient care. Experience has shown us that the standard NIH grant procedures generally take too long to initiate ancillary studies quickly enough to utilize existing large cohorts to full advantage.

The purpose of this FOA is to solicit research grant applications to conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing NIH- or non-NIH-supported clinical trials. The ancillary study can address any research question related to the mission of NHLBI for which the parent study (which can also be an observational study or registry that can provide a sufficient cohort of well-characterized patients) can provide participants, …

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