Clinical Cancer Therapy and Prevention Research (R01) | Apply Online

FAQs: Clinical Cancer Therapy and Prevention Research (R01) - PA-07-356

What is this funding opportunity?

The Clinical Cancer Therapy and Prevention Research (R01) funding opportunity (PA-07-356) is a National Cancer Institute (NCI), National Institutes of Health (NIH) program that supports human-focused cancer research aimed at directly advancing how cancers are prevented and treated. It emphasizes translational and clinical work in people with neoplastic diseases, including therapeutic and preventive clinical studies and trials.

What is the main scientific focus of PA-07-356?

The core focus is moving discoveries from modern cancer science into real intervention strategies in people. The opportunity encourages projects that connect mechanistic insight (for example, from cancer genetics, epigenetics, and cancer biology) to patient-centered testing and evaluation, with the goal of improving outcomes through better interventions.

What are the two main goals of this FOA?

PA-07-356 has two primary goals: (1) stimulating the design and conduct of innovative clinical trials in cancer therapy and cancer prevention, with or without embedded laboratory correlative components; and (2) supporting innovative correlative laboratory studies that are linked to therapeutic or preventive clinical trials, either planned prospectively or conducted retrospectively using trial materials and data.

Does this FOA support clinical trials?

Yes. A central objective is to stimulate innovative clinical trials in cancer therapy and cancer prevention. Trials may be proposed with laboratory correlative components or without them.

Are laboratory correlative studies allowed or encouraged?

Yes. The FOA specifically supports innovative correlative laboratory studies when they are linked to a therapeutic or preventive clinical trial. These correlative studies can be planned prospectively (alongside an intervention) or done retrospectively using materials and data from a clinical trial.

What does it mean for a correlative study to be "linked" to a clinical trial?

It means the laboratory work must be anchored to a defined intervention or clinical trial context. The key requirement is that the study is tied to a specific therapeutic or preventive intervention framework rather than examining specimens without a trial/intervention connection.

Would a study using tumor specimens by itself be considered responsive?

Not if it uses tumor specimens in isolation without being tied to a specific intervention or clinical trial. The FOA states that studies using tumor specimens without linkage to a defined intervention or trial context are non-responsive.

Does the FOA support purely observational biospecimen research?

Not as a standalone concept. Purely observational biospecimen studies are considered non-responsive unless they are explicitly anchored to an interventional study framework (for example, tied to a therapeutic or preventive clinical trial).

What is the funding mechanism used for this program?

The mechanism of support is the NIH Research Project Grant (R01), a standard NIH mechanism for investigator-initiated, multi-year, hypothesis-driven research projects.

Does the FOA specify a set budget amount or a guaranteed number of awards?

No. The announcement does not specify a fixed total budget or a guaranteed number of awards. It states that awards depend on the availability of funds and the receipt of a sufficient number of meritorious applications.

What determines whether an application will be funded?

Funding decisions are contingent on NIH funding availability and on the competitiveness/merit of applications received (described as a sufficient number of high-quality, meritorious applications).

Who is eligible to apply?

Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, state governments, nonprofit organizations (with distinctions noted for those with and without 501(c)(3) status), small businesses, and for-profit organizations (including those other than small businesses). Foreign institutions are also eligible.

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

Yes. Foreign institutions are eligible to apply, supporting non-U.S. applicants and international collaborations, provided the project aligns with NIH rules and the FOA requirements.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of award.

What kinds of collaborations does the FOA encourage?

The FOA highlights moving discoveries into intervention strategies and encourages clinical investigators to work closely with basic scientists studying cancer genetics, epigenetics, and cancer biology, as well as researchers developing new anti-cancer agents. This reflects an emphasis on translational collaboration that connects mechanism to clinical testing.

When was this opportunity posted and what is its status?

This discretionary grant opportunity was posted on April 16, 2007, with a later creation date listed as December 5, 2008. It was later archived on June 7, 2010, which indicates this specific FOA is no longer active in its original form.

Did this FOA have a single deadline or multiple receipt dates?

It used multiple receipt dates rather than a single deadline, meaning applications were accepted on recurring submission cycles as specified in the full announcement.

What does "archived" mean for applicants?

Based on the provided information, the archived status (archive date June 7, 2010) indicates PA-07-356 is no longer active in its original form. Similar opportunities may exist under newer announcements, but that would be outside the scope of the information provided here.

Which NIH/NCI program areas does this FOA align with?

The activity aligns with multiple NIH cancer-related CFDA categories: 93.393 (cancer cause and prevention research), 93.394 (cancer detection and diagnosis research), 93.395 (cancer treatment research), and 93.399 (cancer control). This reflects broad relevance across the cancer research continuum as long as the work remains connected to clinical interventions and trials.

What is the overall purpose of the FOA in practical terms?

In practice, PA-07-356 aims to accelerate clinically meaningful advances in cancer prevention and treatment by funding R01-level projects that (1) run innovative intervention trials, (2) strengthen trials with mechanistic laboratory correlates, or (3) use trial-linked specimens and data to generate insights that directly inform therapeutic and preventive strategies.