Notice of NCI Participation in PA-18-343, "Academic Research Enhancement Award (R15 Clinical Trial Required)"

Notice Number: NOT-CA-18-094

Key Dates
Release Date: July 9, 2018

Related Announcements
PA-18-343

Issued by
National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to inform potential applicants that the National Cancer Institute (NCI) is participating in PA-18-343, "Academic Research Enhancement Award (R15 Clinical Trial Required)."

The following changes have been made in PA-18-343 to reflect NCI's participation in this funding opportunity announcement (FOA):

Part 1. Overview Information

Text has been added to PA-18-343 under each of the headings (below) as follows:

Components of Participating Organizations

National Cancer Institute (NCI)

Catalog of Federal Domestic Assistance (CFDA) Number(s):

93.393, 93.394, 93.395, 93.399

Part 2. Section I. Funding Opportunity Description

National Cancer Institute (NCI)

The National Cancer Institute (NCI) invites applications for R15 AREA grants that propose low-risk clinical trials that addresses the research priorities of its Division of Cancer Treatment and Diagnosis (DCTD), Division of Cancer Control and Population Sciences (DCCPS), and Division of Cancer Prevention (DCP). NCI's definition of low-risk trials is consistent with the criteria outlined in the PA-18-343.

The DCCPS and DCP are committed to developing and testing interventions to reduce cancer risk, incidence, and death and enhance quality of life for patients undergoing cancer treatment and cancer survivors by supporting clinical trials. DCCPS encourages investigator-initiated clinical trial applications that seek to advance cancer prevention and control within clinical, home, and community settings that address racial/ethnic, socioeconomic, gender, and geographic health disparities in cancer prevention and control. DCCPS encourages clinical trials of behavioral interventions for cancer prevention and control in tobacco control, alcohol consumption, obesity prevention, human papillomavirus (HPV) vaccination promotion, and cancer screenings are encouraged for both healthy and survivorship populations. DCP is specifically interested in clinical trial applications that seek to develop and test of interventions (including nutritional compounds or FDA-approved agents) and approaches (including medical devices, cancer preventive surgery, risk-reducing surgery, and non-surgical ablative techniques) to block, reverse, or delay the early stages of cancer (including treatment of preneoplastic lesions and presurgical trials in early stage cancer with the intent of developing an agent/intervention for cancer prevention) including studies examining mechanism and surrogate biomarkers of efficacy; studies for identification, development, and validation of biological markers for early cancer detection and cancer risk assessment; studies of the prevention or treatment of acute and chronic symptoms and morbidities related to cancer and its treatment; and/or studies to improve the QOL of patients.

A list of NCI's scientific priorities can be found at https://www.cancer.gov/research/areas and intervention research priorities for cancer prevention and control can be found at https://cancercontrol.cancer.gov.

The DCTD supports small-scale research projects that propose to conduct early clinical trial evaluations (feasibility testing, first-in-human, and Phase I studies) designed to improve the diagnosis and treatment of cancer. An R15 AREA grant application submitted in response to PA-18-343 for consideration by this division of the NCI may include, but is not limited to, testing of the safety of interventions or approaches involving anticancer drugs, biologics, vaccines, stem cells, imaging agents, imaging devices, or image-guided therapies. Research supported through this FOA may also include the testing of therapeutics, diagnostics, and devices in combination with standard-of-care therapies such as chemotherapy, immunotherapy, surgery, radiotherapy, or any combination of these modalities. DCTD also supports mechanistic-based and biomarker-driven early phase clinical trial aiming to enhance outcome of standard cancer care by incorporation of complementary integrative approaches, such as natural products (e.g., medicinal natural products, diets, nutrients, bioactive food components, and pre/probiotics), and mind-body interventions (e.g., exercise, meditation, and sleep). Applicants should consult the NCI DCTD website at https://dctd.cancer.gov/ to learn more about the research goals of the Cancer Therapy Evaluation Program, Cancer Imaging Program, Radiation Research Program, and the Complementary and Alternative Medicine Program that support early-phase clinical trials through this R15 FOA.

Part 2. Section VII. Agency Contacts

The following text has been added:

Scientific/Research Contact(s):

April Oh, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6709
Email: april.oh@nih.gov

Financial/Grants Management Contact(s):

Carol Perry National
Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Inquiries

Please direct all inquiries to:

April Oh, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6709
Email: april.oh@nih.gov