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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

This Notice of Special Interest (NOSI) informs current awardees that the National Cancer Institute (NCI) is providing the opportunity for supplemental funding to stimulate interest and promote studies on modifiable factors affecting costs of cancer treatment in the context of improving health outcomes. This includes factors associated with the cost of cancer treatment paid by individuals diagnosed with cancer (i.e., out-of-pocket costs ) and/or factor associated with the cost of treatment to healthcare systems or organizations.

Background:

Medical care costs for cancer in the U.S. were estimated as $183 billion in 2015 and are projected to increase to more than $240 billion in 2030. In addition, individuals diagnosed with cancer may experience substantial financial hardship, which adversely impacts quality of life and survival. Cancer survivors experience substantially greater out-of-pocket expenses than do those without a cancer history, with the greatest burdens more frequently occurring among individuals from underserved populations. Despite this, there is limited information on economic drivers of cancer treatment, defined as factors that increase or decrease costs of cancer treatment to patients and the health care system. There is particular interest in the role of modifiable factors on the cost of cancer treatment. Assessing modifiable factors within NCI-funded prospective studies provides an opportunity to better understand variations in cancer treatment costs in the context of studying how innovations can be most effectively deployed to improve the health and well-being of individuals with cancer, consistent with NIH’s Priorities for Health Economics Research (https://grants.nih.gov/grants/guide/notice-files/not-od-16-025.html).

Research Objectives

The research objective for this NOSI is to examine the relationship of patient or health care provider modifiable factors with cancer treatment costs. Studies should contribute to understanding the role of modifiable factors (defined for this NOSI as individual or environmental characteristics, attributes, or barriers that can be changed or intervened upon) on the cost of cancer treatment to patients and/or to health care systems. Examples of modifiable factors include but are not limited to:

• Individual-level patient characteristics such as health literacy, accessibility of transportation to cancer treatment facilities, or financial resources;
• Services or policies that focus on patient modifiable factors;
• Individual-level healthcare provider activities or characteristics such as cost communications with patients, knowledge of guideline-concordant care, or access to supportive care referrals;
• Programs or policies that focus on healthcare provider clinical activities.

For the purposes of this NOSI, treatment includes surgery, radiation therapy, chemotherapy, immunotherapy, hormonal therapy, and other therapies aimed at treating or controlling cancer as well as medical or behavioral interventions intended to address acute or long-term symptoms or effects of cancer or cancer treatment, and may have curative or non-curative intent.

Specific Areas of Research Interest

Possible research interests include, but are not limited to, the effects of modifiable patient and/or provider factors on the costs of cancer treatment to patients and/or health care systems for the following areas:

• Studies of the association of patients social risks and/or unmet non-medical social needs, such as food insecurity or social support, on costs of cancer treatment;
• Studies of the association of patient programs or services on costs of cancer treatment, including but not limited to:
  • Financial navigation or financial counseling services;
  • Symptom screening and access to supportive/palliative care services;
  • Community education/outreach programs designed to reduce disparities in treatment nonadherence, delays and/or interruptions;
  • Patient assistance programs related to non-medical care costs (e.g., transportation, childcare).
• Studies of the association of programs or policies targeting clinical activities by health care providers, such as enhancing shared decision-making and cost communications with patients, increasing adherence to guideline-recommended care, or limiting provision of low-value cancer care and costs of cancer treatment, including but not limited to:
  • Programs designed to change provider behavior or enhance providers clinical skills (e.g., provider training programs, payer models, or provider incentive programs);
  • Innovative uses of technology designed to improve communication, reduce unnecessary care, or increase use of recommended care.

The types of parent grants eligible for this supplement include but are not limited to studies involving prospective collection of cost data and modifiable factors as part of clinical or epidemiologic investigations; evaluations of program or policy interventions; or assessments of natural experiments . Eligible parent grant mechanisms are specified below under Eligibility. Applications may propose studies involving analyses of data previously collected by the parent grant and/or propose collecting new data. Economic analyses may include but are not limited to descriptive cost comparisons, cost benefit, return on investment, or cost effectiveness studies. Only direct costs relevant to cancer treatment from the perspective of either patients or health care systems should be considered. For health care systems, this could include costs for implementing and delivering patient services or health care provider programs such as those listed under Specific Areas of Research Interest (above). For the purposes of this NOSI, the term costs is used to indicate economic values also including (but not limited to) charges or payments for cancer treatment care.

Responsiveness

Applications that are submitted in response to this NOSI must:

1. Include prospective collection of health care system and/or patient costs for individuals receiving cancer treatment in settings reflective of community practice (including academic centers).
2. Analyze associations of cancer treatment costs and modifiable factors (as defined under Research Objectives, above).

Applications nonresponsive to the terms of this NOSI will not be reviewed. The following types of applications would be considered non-responsive and withdrawn without review:

• Do not include prospectively-collected data on costs and modifiable factors;
• Include analyses only of non-modifiable factors (e.g., sex, stage at diagnosis). Such factors may be controlled for in proposed analyses but should not be the focus of analyses;
• Do not include data from individuals diagnosed with cancer and receiving treatment for cancer;
• Do not include individual-level modifiable factors (e.g., propose examining only area-level factors);
• Involve clinical studies of medical interventions, including medications, devices, and surgeries, in which the cost of treatment and subsequent monitoring (e.g., imaging studies and laboratory tests) are not borne by the patient or the health care system, or the patterns of medical care resource utilization are protocol-driven and not necessarily reflective of community practice. This often is characteristic of cancer treatment trials;
• Include collection or analysis of costs for individuals treated for cancer outside the United States;
• Examine geographic variables as the only modifiable factors associated with cancer treatment costs;
• Use standardized cost values (e.g., a CMS fee schedule) rather than actual costs or charges;
• Duplicate (fully or partially) economic analyses proposed in the parent grant. Administrative supplement proposals for parent grants that include economic analyses will be considered. However, the economic analyses in the administrative supplement proposals will need to be distinct from the analyses in the parent grant and justification of the separate analyses proposed in the administrative supplement must be provided.

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

Application and Submission Information

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:

Eligibility:

To be eligible for an Administrative Supplement through this NOSI and the respective FOA, applications must meet the following criteria:

• Administrative supplement applications are limited to currently funded R01, R37, R15, U01, or U19 projects supported by NCI.
• PDs/PIs must hold an active award eligible for PA-20-272 supported through NCI with sufficient time (minimum 1 year) left to complete the studies 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.

Application Due Date: Submissions must be received by June 18, 2021

Budget and Period of Support:

• The budget must not exceed $100,000 in total costs
• 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

Submitting Applications:

• 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-21-055.
• For funding consideration, applicants must include NOT-CA-21-055 (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.
• Page limits: The Research Strategy must not exceed five (5) pages and must summarize the activities of the parent grant that encompass those proposed in the supplemental request and describe how those activities are proposed for augmentation and/or enhancement in the supplemental request by describing the supplement’s purpose, relationship of the supplement request to the parent grant (proposed research much be within scope of the parent grant), and the additional value provided to the underlying funded research (parent grant) of the PI and the collaborating investigators.
• All supplement requests must be submitted electronically through eRA Commons, see PA-20-272 for more information.

Administrative Review and Selection Process

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

Review Criteria:

1. Does the administrative supplement plan reasonably allow for the proposed project to be completed, given the time and budget requested?
2. Are the proposed activities relevant to the parent grant and original work scope?
3. Does the applicant demonstrate satisfactory progress towards achieving the aims of the parent grant, as appropriate to the current stage of the project?
4. Do results from the proposed project for supplemental funding have potential to highly impact costs of cancer treatment by identifying modifiable factors associated with these costs?
5. Does the proposed project for supplemental funding fill an identified gap in the scientific literature on modifiable factors that may affect costs for cancer treatment, including new providing information on factors that have not already been well-documented in the literature?
6. While not a main review criterion, priority may be given to applications from institutions that committed additional funds to support the proposed research beyond that which was awarded as part of the administrative supplement.

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:

Michael T. Halpern, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5818
Email: [email protected]