Omics and Variable Responses to CAM Secondary Analysis of CAM Clinical Trials (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the PAR-07-377 funding opportunity?

PAR-07-377 is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) titled "Omics and Variable Responses to CAM Secondary Analysis of CAM Clinical Trials (R01)." It supports research aimed at explaining why different people respond differently to the same complementary and alternative medicine (CAM) intervention or bioactive food component intervention, using modern "omics" methods.

What is the main goal of this FOA?

The main goal is to identify biological factors that may underlie variable treatment responses (for example, why some participants benefit, some do not, and some may experience adverse effects) by applying high-throughput molecular profiling approaches to existing clinical trial biospecimens and data.

What kinds of research approaches are emphasized?

The FOA emphasizes "omics" and related high-throughput biological profiling approaches such as genomics, proteomics, metabolomics, and similar methods. The intent is to find molecular signatures, biomarkers, pathways, or other biological patterns that correlate with clinical outcomes and heterogeneous responses.

Does this FOA fund new clinical trials?

No. The FOA emphasizes secondary analyses using biospecimens and data that already exist from ongoing or completed clinical studies, rather than funding entirely new clinical trials.

What does "secondary analysis" mean in this context?

In this FOA, secondary analysis means using stored biospecimens and existing trial datasets from ongoing or completed CAM or bioactive food component clinical studies to conduct new omics-based analyses that were not necessarily part of the original trial objectives.

What types of materials are applicants expected to use?

Applicants are expected to leverage stored samples (biospecimens) and existing clinical trial datasets from well-characterized trial populations to examine how molecular variation relates to response, non-response, or adverse outcomes.

What kinds of outcomes or patterns might a project look for?

Projects may look for predictors or correlates of response and variability, such as genetic variants, protein expression patterns, metabolite profiles, or other molecular features that help explain differences in clinical outcomes among participants receiving the same intervention.

What funding mechanism does PAR-07-377 use?

This FOA uses the NIH R01 mechanism, which is generally intended for full-scale, hypothesis-driven projects with substantial scope and well-developed research plans.

Is there a related NIH announcement for exploratory projects?

Yes. This FOA is described as running in parallel with an announcement of identical scientific scope using the R21 mechanism (PAR-07-378), which is typically used for more exploratory or early-stage projects.

Is there a fixed budget cap or a set number of awards?

No. The FOA does not set a fixed budget cap and does not specify a set number of awards. NIH indicates that award size and duration will vary depending on the proposed work, and overall funding levels and the number of awards will depend on application volume, scientific merit, and requested costs and timelines.

Which NIH mission areas or program areas does this FOA bridge?

The FOA bridges complementary and integrative health research and cancer-related prevention research. This is reflected in the CFDA listings: 93.213 (Research and Training in Complementary and Integrative Health) and 93.393 (Cancer Cause and Prevention Research).

What interventions are within scope?

The FOA includes CAM interventions associated with the National Center for Complementary and Alternative Medicine (NCCAM, now NCCIH) and bioactive food component interventions associated with the National Cancer Institute (NCI).

What is meant by variable responses?

Variable responses refers to the idea that individuals can respond differently to the same intervention. The FOA is focused on understanding the biological reasons for these differences, including identifying responders, non-responders, and potentially those at greater risk of adverse effects.

Who is eligible to apply as an organization?

Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses and other for-profit organizations; and a wide range of governmental entities (state, local, territorial, and tribal). The FOA also explicitly notes that foreign (non-U.S.) organizations are eligible, as are eligible federal agencies, and faith-based or community-based organizations.

Are foreign (non-U.S.) organizations eligible?

Yes. The FOA explicitly states that foreign (non-U.S.) organizations are eligible to apply.

Are federal agencies eligible to apply?

Yes. The FOA indicates that eligible federal agencies may apply.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly notes eligibility for faith-based or community-based organizations.

Does the FOA encourage applications from institutions serving underrepresented communities?

Yes. The FOA highlights participation by institutions serving underrepresented communities, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian serving institutions.

Who can serve as Project Director/Principal Investigator (PD/PI)?

The FOA invites any qualified individuals with appropriate expertise and resources to serve as PD/PI and reiterates NIH policy encouraging applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities.

Are multiple PDs/PIs allowed?

Yes. The FOA allows multiple PDs/PIs on a single application, which can support team-based leadership across areas such as clinical trials, biostatistics, and multiple omics platforms.

Can an applicant submit more than one application?

Yes. Applicants may submit more than one application, as long as each submission is scientifically distinct.

Are there multiple submission/receipt dates?

Yes. The FOA includes multiple receipt dates rather than a single deadline.

Is cost sharing or matching required?

No. The FOA states that there is no cost sharing or matching requirement.

Are resubmissions allowed?

Yes. Resubmissions are allowed, but they must include an introduction that addresses prior peer review critiques.

Are competing renewals accepted under this FOA?

The FOA notes uncertainty about whether competing renewals would be accepted and whether the announcement would be reissued. This signals that applicants should not assume long-term continuation beyond the initial award period without future NIH guidance.

What is NIH trying to achieve by funding these secondary analyses?

NIH is encouraging researchers to extract deeper value from existing clinical trials by applying contemporary omics tools to stored biospecimens and datasets. The aim is to move beyond average treatment effects toward a more individualized understanding of efficacy and biology, including identifying responders and non-responders and clarifying mechanisms of action for CAM and bioactive food components.