Quick-Trials for Novel Cancer Therapies and Prevention: Exploratory Grants (R21)

-Purpose. This FOA is intended to promote translational research in new agent/modality development with timely exploitation of new cancer-relevant therapeutic and/or preventive strategies that involve defined molecular targets. Applications are solicited for pilot clinical trials exploring individual anticancer agents/modalities and/or their combinations in the context of specific molecular targets. Applicants may propose Phase 0, Phase I, Phase II, and/or other pilot cancer clinical trials. In addition, patient monitoring and laboratory correlative studies related to clinical trials may be proposed. Applications that explore complementary and alternative approaches for cancer prevention and/or treatment are also encouraged. Clinical trials proposed may be oriented on AIDS-associated malignancies and cancer-related nutritional interventions. Applicants must include the clinical protocol within the Appendix to ensure proper accelerated peer review with the goal of issuing new awards within 6 months of receipt of the grant application. -Mechanism of Support. This FOA will use the NIH exploratory/developmental (R21) grant mechanism for exploratory, pilot projects. Applicants planning to propose fully developed research projects supported by preliminary data should consider a related FOA (PA-07-356) that solicits applications for clinical therapeutic and preventive trials under the NIH research project (R01) grant mechanism. -Funds Available and Anticipated number of Awards: Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications; therefore, the anticipated number of awards is not known.