Correlative Studies with Specimens from Multi Site Trials (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the "Correlative Studies with Specimens from Multi-Site Trials (R01)" opportunity (PA 08-134)?

PA 08-134 is a National Institutes of Health (NIH), National Cancer Institute (NCI) funding announcement that supports R01 research projects focused on translational, correlative cancer studies using biospecimens collected during large, multi-institutional clinical treatment trials and/or prevention trials.

What is the main goal of this funding announcement?

The goal is to make deeper scientific use of trial-linked biospecimens (with clinical annotations) after the primary trial endpoints have been reported, by connecting patient outcomes on specific interventions to cellular and molecular characteristics of disease. The practical aim is to improve prediction of response and to guide better future therapies and prevention strategies.

What kinds of research does this FOA prioritize?

The FOA prioritizes translational, correlative studies that test relationships between intervention outcomes (for example, response, resistance, toxicity, recurrence, or progression patterns) and measurable characteristics of a patient's cancer or biologic state.

What does "correlative" mean in the context of this FOA?

In this FOA, "correlative" refers to studies that link clinical outcomes observed in a trial (tied to specific interventions) with molecular and cellular measurements from biospecimens, to help explain why an intervention worked for some participants and not others and to identify markers that may be useful for future clinical decisions.

What kinds of outcomes are examples of the intervention results that may be correlated with biospecimen findings?

Examples listed include response, resistance, toxicity, recurrence, and progression patterns, as well as other trial-relevant outcomes tied to a specific clinical treatment or prevention intervention.

What types of biospecimen analyses and data are within scope?

The announcement emphasizes molecular and cellular characterization across a wide range of assays and data types, including genotypic and phenotypic profiling and analyses at the genome, epigenome, gene expression, and protein levels, as well as other protein and non-protein biomarkers.

Is this FOA meant for general biomarker discovery without clinical context?

No. A defining requirement is that the biospecimens must be linked to specific interventions and trials. This is not described as a general biobanking or discovery-biomarker program disconnected from clinical context.

Do the biospecimens need to be connected to specific trial arms or interventions?

Yes. The biological materials must be connected to clearly defined trial arms or prevention interventions so that molecular findings can be interpreted against known exposures and outcomes.

What is the translational expectation for results produced under this FOA?

The FOA is designed to produce results that are more likely to translate into clinically meaningful predictions or next-step clinical development ideas, such as markers that could be used to stratify patients, refine clinical decision-making, or suggest new therapeutic targets.

Which NCI groups sponsor this FOA?

The FOA is cooperatively sponsored within NCI by the Cancer Therapy Evaluation Program (CTEP), the Cancer Diagnosis Program (CDP), and the Cancer Biomarkers Research Group (CBRG).

What does the cooperative sponsorship suggest about the kind of projects NCI is interested in?

The sponsorship signals interest in studies that bridge therapeutic evaluation, diagnostic insight, and biomarker development, rather than staying purely mechanistic or purely observational.

Is team science or collaboration emphasized?

Yes. The announcement underscores team science and expects active interactions between basic researchers and clinical investigators so that assay design, specimen handling considerations, clinical endpoint definitions, and interpretation remain grounded in trial realities and can feed back into improved intervention and drug development strategies.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH Research Project Grant (R01) mechanism.

What does using the R01 mechanism imply about project maturity?

The FOA describes R01 projects as more mature and hypothesis-driven, with a defined research plan and sufficient preliminary rationale to justify a full-scale investigation.

Is there a related announcement for exploratory or earlier-stage projects?

Yes. The FOA ran in parallel with a companion announcement with the same scientific scope using the R21 mechanism (PA 08-133), which is typically intended for earlier-stage, exploratory, or developmental work.

Who is eligible to apply?

Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), state and local government entities (including independent school districts and special district governments), and additional eligible applicants such as federal agencies.

Are non-U.S. organizations allowed to apply or participate?

Yes. The FOA allows participation by non-U.S. entities (foreign organizations), regional organizations, and U.S. territory or possession agencies.

Is cost sharing or matching required?

No. The listing indicates there is no cost sharing or matching requirement.

What cancer research areas does this program cover?

The program is categorized under multiple cancer-related CFDA numbers spanning cancer cause and prevention research, cancer detection and diagnosis research, and cancer treatment research. This reflects a broad translational scope, as long as the work is grounded in specimens from multi-site trials tied to defined interventions.

When was this opportunity posted and when did it close?

It was posted on April 4, 2008. The record indicates an original closing date of May 7, 2011 and a then-current closing date of November 17, 2011, with an archive date of December 17, 2011.

Where was the full announcement published?

The full announcement was provided through the NIH Grants Guide.

Who should be contacted for access or linking issues related to the announcement?

Support contacts for access or linking issues were routed through the NIH Office of Extramural Research (OER) webmaster.

What is the basic rationale for focusing on specimens from large, multi-institutional trials?

The FOA is built on the idea that major trials often collect tumor samples and other biological materials along with detailed clinical annotations, and that these resources can support additional high-impact analyses after primary trial endpoints are reported.

Does the FOA focus only on treatment trials, or also on prevention trials?

It explicitly includes both clinical treatment trials and/or prevention trials, as long as the biospecimens are trial-linked and annotated and the proposed research is correlative and translational.