Correlative Studies with Specimens from Multi Site Trials (R21) | Apply Online

Opportunity Summary:

The Correlative Studies with Specimens from Multi Site Trials (R21) opportunity (Funding Opportunity Number PA 08 133) is a National Institutes of Health program, led through the National Cancer Institute, that is meant to push cancer research in a very practical, translational direction. The central idea is to fund correlative studies that make direct use of annotated tumor samples and other biospecimens that were collected as part of large, multi-institution clinical treatment trials or prevention trials. In other words, the program is not about starting a new trial or gathering a brand-new sample set from scratch; it is about taking advantage of valuable specimens that already exist from organized trials, and using them to learn why certain patients responded the way they did to a specific intervention.

A defining feature of this FOA is that the biospecimens must be linked to a specific clinical or prevention intervention and to known trial outcomes. The intent is to connect what happened clinically (response, resistance, progression, recurrence patterns, prevention outcomes, and similar endpoints) with what can be measured in the specimens at the cellular and molecular level. The announcement highlights work that ties intervention outcomes to patient and disease characteristics captured through modern biology, such as genotypic and phenotypic tumor profiles. Examples include genomic alterations, epigenomic patterns, gene expression signals, protein markers, and other non-protein molecular markers. The broader goal is to identify patterns that can help predict who benefits from current therapies or preventive approaches, clarify mechanisms of response and resistance, and ultimately inform the design of better treatments and prevention strategies going forward.

This FOA is cooperatively sponsored within NCI by three groups: the Cancer Therapy Evaluation Program (CTEP), the Cancer Diagnosis Program (CDP), and the Cancer Biomarkers Research Group (CBRG). That combination signals that the program sits at the intersection of treatment evaluation, diagnostic science, and biomarker development. It is geared toward studies that are tightly connected to real clinical questions and real patient outcomes, rather than purely exploratory laboratory work that is disconnected from intervention data.

Because these projects depend on both high-quality specimens and accurate clinical annotation, the FOA makes it clear that collaboration is not optional in practice. Applicants are expected to build projects that involve meaningful interaction between basic researchers and clinical investigators. The aim is to ensure that assays and analyses are biologically sound and technically rigorous, while also staying grounded in the clinical trial context, including how patients were treated or followed, what endpoints were measured, and what the specimens represent in terms of timing and disease state. The translational expectation is that successful projects will generate insights that can feed back into drug development, patient stratification, and the selection or refinement of interventions in future studies.

The funding mechanism is the NIH Exploratory/Developmental Grant (R21). That mechanism is typically used for early-stage or concept-driving research that can be completed with a limited budget and timeframe, often to establish feasibility, generate preliminary evidence, or test a promising approach before a larger-scale effort. In this FOA, the R21 format is positioned as a way to catalyze innovative correlative studies using existing multi-site trial specimens. The announcement also notes that it runs in parallel with a companion FOA of the same scientific scope that uses the R01 mechanism (PA 08 134), giving applicants a choice depending on the maturity and scale of their proposed work.

On basic administrative details, this is a discretionary grant opportunity in the health area, tied to CFDA programs 93.393 (Cancer Cause and Prevention Research), 93.394 (Cancer Detection and Diagnosis Research), and 93.395 (Cancer Treatment Research). The award ceiling listed is $200,000, and there is no cost sharing or matching requirement. The opportunity was posted April 4, 2008, with an original and final closing date of May 7, 2011, and an archive date of June 7, 2011.

Eligibility is broad and spans many common research-performing organization types. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses, as well as state governments. The FOA also allows additional categories that are sometimes excluded from other NIH opportunities, including eligible federal government agencies, non-U.S. entities (foreign organizations), regional organizations, and U.S. territory or possession agencies. The listing notes that some eligibility details require referring to the FOA text for clarification.

Taken together, PA 08 133 is best understood as a targeted NCI effort to turn the investment already made in major multi-site trials into deeper biological understanding. It encourages researchers to mine trial-linked specimens for molecular and cellular signals that explain or predict clinical outcomes, with the expectation that those findings will sharpen how interventions are chosen, developed, and improved in future cancer treatment and prevention work.

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