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PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

Purpose

The purpose of this Notice is to encourage currently funded NCI extramural investigators to apply for administrative supplements to study cancer control and prevention in low- and middle-income country (LMIC) settings using economic or costing data and methods.

Background

The global health and economic burden of cancer is increasingly concentrated in LMICs, where economic factors at the individual, community and policy levels have substantial relevance for and impact on cancer outcomes. Costs can pose a substantial barrier to access to treatment, for example, which is likely to have a disproportionate impact in LMICs. Cancer diagnosis and treatment impose a high financial burden on patients and their families, including direct medical and non-medical costs, as well as indirect costs, such as lost income. Indeed, cancer is associated with the highest economic loss among leading causes of death worldwide. Development of the human, technical, and infrastructure resources needed to provide cancer care have the potential to place an enormous strain on already overstrained health systems. Moreover, implementation barriers for effective cancer control interventions in LMICs are often related to cost and economic conditions. Thus, global health experts have identified affordability of cancer care, value-based care, and health economics as key priority areas for cancer research in LMICs.

Evaluations of the economic costs of cancer and cancer control vary across countries and settings based on the disease burden, the availability of healthcare resources, access to care utilization and outcomes data, ability to measure financial burden or toxicity, and healthcare practices. There is a lack of data and rigorous research to address economic aspects of cancer and cancer control in LMICs. Little is known about the economic impact of a cancer diagnosis for patients and their families in LMICs. A 2016 bibliometric analysis estimated that at that time only 8% of published economic evaluations of health interventions addressed low- or lower-middle income countries. Additionally, most evidence regarding cost effectiveness of cancer screening and treatment comes from high- or upper-middle-income countries, and existing methods for health economic analyses are largely based on high-income populations and may not adequately account for different health and economic contexts. Economic modeling can also be used to guide policy decisions and inform selections between different cancer control strategies. But the lack of economic data from LMICs is a challenge for countries in the process of prioritizing interventions and programs for cancer control. An analysis of 158 national cancer control plans conducted in 2018 showed that only 16 plans provided details about costing and budgeting. More studies are needed in low- and lower-middle-income countries to generate data to inform and build the economic case for cancer control and prevention in LMICs.

Research Objectives

This supplement opportunity encourages research that uses economic or costing data and methods to study cancer control in LMICs. Research may involve the use of economic data to assess medical costs associated with cancer control or care, to understand non-medical costs, or to study the application of economic data to inform policy decisions. Studies may utilize a range of possible approaches including original data collection, secondary data analysis, modeling using available data, or methods development. The parent award need not have included an economic outcome or measures. However, the supplemental funding request must propose to enhance the parent award through incorporating economic or costing analyses or methods to extend the existing research aims. Applicants are encouraged to leverage existing resources and partnerships, and to design projects that can reasonably be completed within the given time and budget.

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

Individual level

• Studies of direct and indirect costs of cancer control and/or care (including financial toxicity associated with treatment)
• Studies of indirect or hidden costs associated with cancer care and survivorship
• Studies of the financial impact of household spending on tobacco or alcohol products
• Behavioral economic studies relevant to cancer control at the individual or provider level

Community level

• Assessing affordability or cost-effectiveness of an intervention or implementation strategy being tested in an LMIC setting
• Studies of the application and usability of costing tools
• Understanding patient and provider valuation of cancer related health outcomes

Health System and Policy level

• Development and testing of a model of the potential economic impact of a change in cancer control policy or practice
• Studies of tax policies for cancer prevention (such as taxes on cigarettes and alcohol)
• Studies of the factors influencing direct and indirect economic burden of cancer in different settings
• Development or validation of methods to assess costs or economic outcomes related to cancer in LMICs

Requirements

Applications responsive to this NOSI must:

• Focus on application of economic methods and approaches to cancer control in LMICs; and
• Include LMIC-based investigators in the research team who are involved in the development of the research aims and in the performance of the research

Applications not responsive to this NOSI include:

• Projects that engage collaborators only in high-income countries (HICs)

Eligibility

• Administrative supplement applications are limited to currently funded R01, R21, R33, R37, P01, P20, P30, P50, U19, U01, UH3, or U54 projects supported by NCI. Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• PDs/PIs must hold an active award supported by NCI with sufficient time (minimum 1 year) left to complete the study proposed after the supplement has been awarded within the existing project period.
• The proposed project for supplemental funding is required to be within the scope of the parent award and be a logical extension of the original aims.
• For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
• The awardees of multi-projects must submit their request as a single project application for the supplemental funding.

Application and Submission Information

Administrative supplements may only be used to meet increased costs that are within the scope of the approved award but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted.

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date: Applications can be submitted on a rolling basis between April 4, 2023 - May 30, 2023, at 5:00 PM local time of applicant organization for FY 2023 funding. The NOSI will expire May 31, 2023.
• For funding consideration, applicants must include “NOT-CA-23-052” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as “NOT-CA-23-052”.
• Applicants are encouraged to discuss their application with the scientific contact listed below prior to submission to ensure responsiveness and facilitate processing of this application.
• Applicants are also strongly encouraged to notify the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.

Budget and Period of Support

• Budget requests cannot exceed $150,000 in total costs and must reflect the actual needs of the proposed budget.
• At least one full year on the parent grant must remain at the time of funding. The application budget is limited to 1 year only.
• Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• If an applicant anticipates a balance of 50% or more of the current total costs for the parent grant, please contact the scientific research contact prior to submitting an application.
• Requests must reflect the actual needs of the proposed project. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as the research objectives are within the original scope of the peer reviewed and approved project (i.e., award); supplements designed to meet cost increases for unanticipated expenses within the original scope of the project will not be considered.
• Only one supplement application per grant will be accepted for consideration through this NOSI.

Page limits

These sections have the following page limits:

• Project Summary/Abstract: 30 lines of text
• Project Narrative: 3 sentences
• Research Strategy: 5 pages
• Biographical Sketch: for Senior/Key Personnel and Significant Contributors only

Administrative Review Process

NCI will conduct administrative reviews of submitted applications and will support the most meritorious applications submitted for consideration, based upon availability of funds.

Criteria:

• Does the administrative supplement reasonably allow for the proposed project to be completed, given the time and budget requested? Does the proposed project for supplemental funding fill an identified gap in the scientific literature that advances the use of economic methods and data for global cancer control?
• Does the proposed project adequately respond to real world needs and involve the appropriate stakeholders in the research?
• Are the proposed methods rigorous and appropriate to the research question? 
   

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.

Applicants are encouraged to discuss their application with the scientific/research contact listed in this NOSI prior to submission.

Inquiries

Please direct all inquiries to:

Mark Parascandola, PhD, MPH
Center for Global Health
National Cancer Institute (NCI)
Telephone: 240-276-6871
Email: paramark@mail.nih.gov

Financial/Grants Management Contact

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dawn.mitchum@nih.gov