Cooperative Agreement to Develop Targeted Agents for Use with Systemic Agents Plus Radiotherapy (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the name and mechanism of this funding opportunity?

The opportunity is titled Cooperative Agreement to Develop Targeted Agents for Use with Systemic Agents Plus Radiotherapy (U01) and is identified as PAR-16-111. It uses a U01 cooperative agreement mechanism, which generally involves more active scientific or programmatic involvement by the funding agency than a typical research project grant.

Which agencies are sponsoring this opportunity?

This is a National Institutes of Health (NIH) funding opportunity through the National Cancer Institute (NCI), under the U.S. Department of Health and Human Services (HHS).

What is the main purpose of PAR-16-111?

The main purpose is to strengthen and standardize preclinical testing for new cancer treatment combinations, specifically to generate clearer and more reliable preclinical evidence about which molecularly targeted anti-cancer agents meaningfully improve outcomes when added to standard-of-care chemoradiation regimens used for solid tumors.

What kinds of therapies or combinations does the FOA focus on?

The focus is on NCI-prioritized, molecularly targeted anti-cancer agents and how they perform when layered onto existing treatment approaches that already combine radiotherapy with systemic chemotherapy. In other words, the preclinical work is meant to evaluate targeted agents as add-ons to established chemotherapy plus radiation therapy regimens for solid tumors.

Why is NCI emphasizing targeted agents added to chemoradiation?

The FOA reflects the idea that many targeted drugs appear promising, but the field needs better head-to-head and decision-ready preclinical data to determine which combinations are truly worth advancing into clinical trials. The goal is to support more rational prioritization of combination strategies, rather than relying on inconsistent or exploratory-only preclinical findings.

What types of studies are expected in an application?

Applications are expected to propose rigorous in vitro and in vivo studies. The FOA emphasizes work that goes beyond exploratory screening and instead produces validated, high-quality datasets that can support go/no-go decisions about which targeted agent combinations should advance toward clinical testing.

What does "decision-ready preclinical data" mean in this context?

Based on the description, it refers to preclinical results that are robust and comparable enough to credibly support prioritization decisions, including whether a targeted agent combination should move forward into clinical evaluation. The program is oriented toward creating evidence that can be used to make clear go/no-go calls, rather than producing preliminary or purely exploratory signals.

Is this opportunity aimed at clinical trials or preclinical research?

It is aimed at preclinical research intended to inform and accelerate later clinical evaluation. The broader translational goal is to shorten the path from preclinical discovery to clinical testing by identifying combination strategies that are more likely to improve efficacy in patients with solid tumors.

What is the significance of the U01 cooperative agreement mechanism?

A U01 mechanism typically indicates substantial involvement by NCI compared with a standard grant. While awardees still propose and conduct the research, the cooperative structure generally implies that NCI expects an active partnership related to items such as project coordination, milestone setting, data standards, and alignment with program priorities.

What is the overall program goal beyond producing datasets?

The stated goal is translational: to make preclinical evidence stronger and more comparable so that NCI-supported investigational new drugs or agents (INDs) can be prioritized more effectively for combination with chemoradiotherapy, and then moved more quickly into clinical testing and ultimately routine practice if they demonstrate benefit.

When was this opportunity posted?

The opportunity was posted on February 23, 2016.

What are the closing dates for this opportunity?

The original closing date and the current closing date are both listed as December 14, 2017.

What is the maximum award amount (award ceiling)?

The listed award ceiling is $450,000.

How many awards were anticipated?

The program anticipated making about three awards.

Who is eligible to apply?

Eligibility is broad and includes: public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, nonprofits (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), small businesses, and other applicants as allowed under the FOA's additional eligibility language.

Does the FOA limit participation to academic institutions only?

No. The eligibility language explicitly includes a wide range of organization types, including nonprofits, government entities, tribal organizations, for-profit organizations (other than small businesses), and small businesses, in addition to public and private institutions of higher education.

What kind of research teams is this FOA geared toward?

It is geared toward teams capable of conducting robust preclinical combination-therapy studies that can credibly inform which targeted agents should be prioritized for clinical development alongside chemoradiotherapy for solid tumors.

What cancer types are emphasized?

The FOA emphasizes solid tumors, particularly in the context of combinations added to standard-of-care regimens that include systemic chemotherapy plus radiotherapy.

How does this FOA relate to NCI investigational new drugs or agents (INDs)?

The program is designed to support a more evidence-driven process for prioritizing NCI-supported INDs or agents that are most likely to show clinical activity when combined with chemotherapy plus radiation therapy, based on higher-quality preclinical evidence.

What is meant by "standardizing preclinical testing" in this announcement?

From the information provided, the intent is to improve the quality and comparability of preclinical evidence across studies so that results are more reliable for decision-making about advancing combinations into clinical trials.