Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R21 Clinical Trial Not Allowed)

Organization
NCI
Type
NIH
Application or LOI Due Date
01-22-2021
Comments
LOI due 1/22/21 for application due date of 2/22/21. Other deadlines: 5/27/21 and 9/29/21 - LOI required and due 30 days prior to app due date.
Brief Description

Purpose

This Funding Opportunity Announcement (FOA) solicits grant applications proposing exploratory research projects focused on early-stage development of highly innovative technologies that improve the quality of the samples used for cancer research or clinical care. This includes new capabilities to address issues related to pre-analytical degradation of targeted analytes during the collection, processing, handling, and/or storage of cancer-relevant biospecimens. The emphasis of this FOA is to support the development of highly innovative technologies capable of maximizing or otherwise interrogating the quality and utility of biological samples used for downstream analyses. This FOA will support the development of tools, devices, instrumentation, and associated methods to preserve or protect sample integrity, or establish verification criteria for quality assessment/quality control and handling under diverse conditions. These technologies are expected to accelerate and/or enhance research in cancer biology, early detection, screening, clinical diagnosis, treatment, epidemiology, or address issues in cancer health disparities, by reducing pre-analytical variations that affect biospecimen sample quality.

Applications involving an existing technology not yet demonstrated in the cancer-relevant application being proposed are also within the scope of this FOA but must involve significant, additional technical modifications to allow for the proposed cancer-relevant context of use or some significant question of feasibility persists for achieving the proposed aims. If the research focus for the application involves an existing technology, a clear description of the feasibility risk justifying the use of the R21 mechanism must be included in the application. Applicants are encouraged to reach out to the Scientific/Research Contact below with any questions.

This FOA utilizes the R21 award mechanism for exploratory/developmental projects. The R21 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase. In this phase, technical feasibility of the proposed technology or methodology should have not yet been established. Preliminary data are not required but are accepted if available. If preliminary data are sufficient to suggest the feasibility of the approach is established, then consideration should be given to submitting to the companion R33 FOA (RFA-CA-21-006).

  

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The IMAT Program

Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI's other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct population-scale studies, address and reduce disparities in clinical care, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of four separate FOAs that cover the following two areas

  • Molecular and Cellular Analysis Technology Development for Cancer Research is intended to support the development of technologies that are novel and potentially transformative to the molecular and cellular analysis of cancer, which may, in turn, accelerate basic or clinical cancer research. Applications must offer novel measurement, probing, or targeting of cancer-relevant targets at the molecular or cellular level.
    • RFA-CA-21-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
    • RFA-CA-21-004 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology
  • Cancer-Relevant Biospecimen Science Technologies is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. Applications must offer novel approaches for procurement, preservation, and/or isolation of proteins, DNA, RNA, and other small molecules from biospecimens or otherwise assess their biological integrity. The emphasis is on reducing the impact of pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or clinical care.
    • RFA-CA-21-005 (this FOA, R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
    • RFA-CA-21-006 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.

Additional information about the IMAT Program and its individual FOAs can be found here.

Specific Research Objectives and Scope of this FOA

The proposed projects must be focused on innovative, biospecimen science-relevant technologies and methodologies that either improve the quality and utility of biospecimens and/or samples derived from biospecimens for cancer research and/or clinical care or otherwise seek to measure the quality of those samples and determine their fitness for downstream analyses. The proposed technology may be targeted for the needs of basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or for broad potential use in cancer research.

In addition, all projects proposed in response to this FOA must involve all of the following general attributes:

  • Potential for substantial improvements over current approaches and/or adding qualitatively new research capabilities.
  • Offers novel capabilities that may be judged by appropriate experts as potentially transformative to research in laboratory and/or clinical settings, and beyond providing incremental improvements to existing capabilities.
  • Rigorous study design with a verifiable approach, based on well-defined, performance measures (see below for a description of performance measures). An application lacking performance measures will not be reviewed.

For details on addressing these requirements, see Section IV. Application and Submission Information.

Responsive Technologies and Scientific Scope

Responsive technologies include relevant techniques, tools, instrumentation, devices, and associated methods. These technologies must focus on offering improved capabilities for procuring, preserving and/or preparing cancer biospecimens for basic or clinical research purposes with a focus on improving the integrity of targeted molecular and/or cellular features or otherwise allow for assessment of analytical integrity in specimens of unknown quality.

General areas of interest include, but are not limited to, the following:

  • Novel technologies to benchmark or otherwise assess the biological integrity of classes of molecular analytes (e.g., determine fitness-for-purpose for targeted analysis of protein complexes, non-coding RNA, classes of epigenetic lesions, etc.);
  • Novel technologies and techniques to provide high-quality preservation of specific classes of molecules, sub-cellular components, whole cells or bulk tissue;
  • New methods, tools, and procedures that may generally facilitate the preparation of biospecimens for classes of molecular analysis (e.g., genomic or RNA sequencing, mass spectrometry-based protein profiling or metabolite analysis, etc.) or improve the representative quality of patient-derived models;
  • Technologies that can allow for rigorous and/or expeditious collection of various relevant types of biospecimens while ensuring sufficiently high quality for epidemiological cancer research;
  • Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and,
  • Technologies to facilitate the collection of relevant biological specimens and data for examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).

Non-Responsive Projects

The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:

  • Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question (i.e., traditional biological-hypothesis driven research) and NOT in the novel technical capability being developed;
  • Use of existing technologies (for which a proof-of-concept has already been demonstrated in a cancer-relevant biological system) that may be ready for advanced development and validation without substantial further developmental efforts;
  • Technologies for whole-body or in vivo imaging;
  • Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
  • Biomarker discovery or biomarker validation;
  • Development of specific contrast agents (though generalizable contrast agents are allowed);
  • Development of drugs or therapies; and/or
  • Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.

Because all applications must include performance measures, an application that lacks performance measures as determined by the NCI program staff will not be reviewed.

As there are several unique review considerations for this FOA, applicants must address the requested items outlined for the Research Plan in Section IV.2. Application and Submission Information.

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the Scientific/Research Contact listed below.

Alternative Opportunities

Related IMAT FOA: Applicants proposing projects that are beyond questions of feasibility, but still require further development and validation should consider applying to the companion FOA (RFA-CA-21-006), which uses the R33 mechanism. Further development encompasses optimization and scaling of the technology or merging with complementary technologies to improve the overall functionality.

NOTE: Applications proposing to merge complementary technologies without a substantial requirement for further development or a clear need for analytical validation are beyond the scope of the IMAT program solicitations altogether.

Other technology-related funding opportunities. Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software development solutions should consider one of the Informatics Technologies for Cancer Research (ITCR) opportunities. Researchers who emphasize the assessment of whole-body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP) for information on appropriate funding opportunities.

Annual Meeting

An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the development of technologies for cancer research and clinical care for cancer patients. All investigators supported through this FOA are required to attend this meeting each year, lasting 2-3 days, unless otherwise notified by NCI program officials.

See Section VIII. Other Information for award authorities and regulations.