The National Cancer Institute released two funding announcements in recent weeks that offer exciting opportunities for investigators to improve patient outcomes and contribute major breakthroughs in the field of cancer research.
Integrating Biospecimen Science Approaches into Clinical Assay Development (U01), will support research that investigates and moderates challenges facing clinical assay development due to biopsy biospecimen preanalytical variability. Biopsy collection, processing, and storage procedures can all have significant impact on the analytical performance of clinical biomarkers; false positive or negative results from the evaluation of biomarkers can directly affect patient diagnosis, treatment, and outcomes and can lead to over-treatment, under-treatment, or incorrect treatment. In addition, measurement and validation of clinically relevant biomarkers are increasingly challenging as reliance on smaller biospecimens grows and new biomarkers and analysis platforms emerge. The need to increase reliability and reduce time needed for assay development is imperative.
Eligibility: This FOA will fund a collaborative, interdisciplinary network that integrates clinical researchers with academic and private sector scientists in projects focused on preanalytical challenges presented by small biopsies. Applicant must have an assay that has been analytically validated within its intended clinical context under particular preanalytical conditions. Preliminary data should define the current status of the assay as well as justify support for optimization and usability in a clinical trial.
Application budgets are limited to $250,000 direct costs per year for up to five years.
Letter of Intent due: May 22, 2016
Full application due: June 22, 2016
NCI Clinical and Translational Exploratory/Developmental Studies (R21), will support exploratory/ developmental projects in the advancement of novel anti-cancer agents, diagnostic tools, and clinical approaches in treatment, symptom management, and prevention of common or rare tumors. These studies may involve considerable risk, but may lead to a breakthrough in a particular area, and/or to the development of novel techniques, agents, methodologies, models, or applications (pre-clinical or clinical). Focus areas with examples include but are not limited to:
- Clinical Studies: Exploratory Phase I or small, non-randomized Phase II trials of new agents; Clinical studies for preliminary evaluation of safety and efficacy of imaging tools/techniques; Pilot trials of new radiation modalities
- Correlative Studies/Biomarker Development: Studies that correlate pathology image data with cancer diagnosis and prognosis; Discovery of early validation of biomarkers elucidating mechanisms of action of cancer preventive interventions
- Target and Agent Discovery and Development: Work that identifies new tumor or tumor micro-environment molecular or immunologic targets
- Model Development and Analysis: Development of in vivo or in vitro models of common or rare tumors; Computational, mathematical, and animal models that can be used to assess imaging systems
Up to $275,000 in direct costs over a two year project period.
Application deadline June 19, 2016