Key Dates

Related Announcements

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 informs current awardees of National Cancer Institute (NCI) cancer prevention and symptom management clinical trial grants of an opportunity for supplemental funding of eligible NCI-supported grant and cooperative agreement awards so that awardees can undertake and evaluate recruitment and retention strategies and thereby facilitate the success of their clinical trial programs.

Background:

Efficient recruitment and retention of diverse clinical trial participants has been notoriously difficult to achieve in all disease settings. Prominent barriers to timely completion of accrual to cancer prevention and symptom management clinical trials include organizational factors (e.g., inadequate staffing, limited clinic hours, complex procedures and urban locations), participant reluctance (due to research risk concerns or limited awareness of clinical trials), logistical issues (e.g., transportation, time commitment) and objectionable protocol elements (e.g., extra clinic visits, invasive procedures, strict eligibility criteria and agent toxicity) have been. In addition, these factors along with institutional, socio-economic, and cultural disincentives contribute to the inadequate enrollment of minority and underserved populations. Robust strategies are clearly needed to overcome these obstacles across all populations. Furthermore, reports of rigorous evaluations of effects of recruitment and retention strategies would provide evidence-based guidance for future clinical trial recruitment planning, which is currently lacking.

Research Objectives:

The NCI is providing this opportunity for support of implementation and evaluation of promising clinical trial recruitment and retention strategies for cancer prevention, cancer control, and care delivery clinical trials, as well as quality-of-life studies embedded within treatment and imaging studies. The research solicited through this opportunity includes but is not limited to strategies that are directed toward NIH-designated U.S. health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities as well as older adult populations. Research proposed for supplemental funding may include one or more strategies and may be applied to one or more studies or sites. Applications should include a prospective plan to evaluate the performance of the proposal as well as the effectiveness of the proposed strategy. Effectiveness of the strategy may include comparison with another strategy, participant surveys, staff satisfaction surveys or achievement of pre-specified recruitment and retention milestones.

Examples of the types of research strategies that may be supported through supplemental funding requested and obtained through this NOSI and PA-20-272 include but are not limited to the following:

• Recruitment communication training programs for staff
• Database screening tools
• Digital approaches to reducing study burden (e.g., telehealth)
• Outreach to potential participants’ health care providers (e.g., non-oncology specialists such as pulmonologists, gastroenterologists, geriatricians, primary care providers, general surgeons)
• Social media networks (Facebook, Twitter, LinkedIn, Tumblr)
• Designated accrual sites for minority/underserved populations
• Dedicated recruitment specialists
• Monetary reimbursement
• Use of portable imaging and point-of-care technologies
• Communication devices (tablets and smartphone apps to collect data and monitor compliance
• Mobile research staff for home visits
• Recruitment feasibility surveys
• Compliance tracking tools
• Decision aids

Applications responsive to this NOSI must:

• Describe potential problems and approaches to overcome the challenges;
• Clearly describe the end user of the strategy;
• Include a plan to prospectively evaluate the performance of the proposed research as well as the effectiveness of the proposed strategy with pre-defined metrics;
• Provide a well-reasoned rationale for use of the proposed strategy in terms of the trial type (i.e., prevention, symptom control, end-of-life trial) and Phase (0, I, or II) and study population;
• Discuss potential contribution to the field and applicability in both the current environment and in the future post-COVID environment;
• If proposing to implement and evaluate a previously used strategy, provide justification for use of this tool in the proposed setting;
• If proposing to implement and evaluate a new strategy, highlight the innovative aspects; and
• Indicate if the strategy is potentially generalizable or adaptable to other studies, sites, cohorts, and/or settings or if it is intended to be study-, site-, cohort(s)- or setting-specific.

Applications not responsive to this NOSI include those that:

• Propose work that is included in the original funded recruitment plans;
• Include a plan that is not reasonable for the proposed project to be completed, given the time and budget requested;
• Propose a poorly defined strategy that will require further planning before implementation and evaluation can begin;
• Lack an unbiased approach to evaluation of the strategy outcomes; and/or
• Lack consideration of applicability to diverse populations.

All applicants are encouraged to discuss their applications with the scientific/research contact listed in this NOSI (below) prior to submission.

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 the funding opportunity announcement used for submission must be followed, with the following additions:

Eligibility and Eligible Individuals (Program Director/Principal Investigator):

Only existing awardees of the programs listed below are eligible to apply.

• PAR-18-559, Cancer Prevention and Control Clinical Trials Grant Program
• RFA-CA-18-015, NCI Community Oncology Research Program (NCORP) Research Bases
• RFA-CA-18-016, NCORP Community Sites
• RFA-CA-18-017, Minority/Underserved Community Sites
• RFA-CA-18-018, Prevention of HPV-related Cancers in HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers
• RFA-CA-18-029, Cancer Prevention Clinical Trials Network (CP-CTNet): CP-CTNet Sites
• RFA-CA-18-030, Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC)
• RFA-CA-19-031, Cancer Prevention Clinical Trials Network (CP-CTNet): CP-CTNet Sites

For supplements to parent awards that include multiple program directors/principal investigators (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. If the PD/PI of the supplement application is not the PD/PI of the parent award, a letter of support from the contact PI of the parent award must be provided. The project period for the parent award must be active, and cannot be in a no-cost extension, for the 1 year of the administrative supplement application/project/award.

Application Due Dates:

Applications can be submitted during the 6 weeks before Application Due Dates of June 15, 2021, May 16, 2022, and May 15, 2023, until 5:00 PM local time of applicant organization, for possible funding in FY2021, FY2022, and FY2023, respectively.

The Expiration Date of this NOSI is May 16, 2023.

However, continuation of this NOSI is contingent upon availability of funds, and the NOSI may be terminated before the current expiration date.

Budget:

• Supplement budget requests cannot exceed $100,000 in direct costs exclusive of Facilities and Administrative costs on sub-awards, and the budget cannot exceed the direct costs of the current parent award.
• 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, or the cost increases are for unanticipated expenses within the original scope of the project.
• Requests are permitted for 1 year of support only.
• Modular and categorical budgets are permitted.
• The earliest anticipated start date is September 1, 2021.

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-21-070.”
• For funding consideration, applicants must include “NOT-CA-21-070” (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 section of the application is limited to 6 pages.

Review and Selection Process:

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds. Additionally, NCI program staff will evaluate applications using the following selection factors:

• Is the proposed work within the scope of the parent award, but beyond the original recruitment plans?
• Does the administrative supplement plan reasonably allow for the proposed project to be completed, given the time and budget requested?
• Is the strategy ready to be initiated as described?
• Are the identified end user(s) appropriate?
• Does the proposed project include strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Are potential problems, alternative strategies, and benchmarks for success presented?
• Is a well-reasoned rationale provided for use of the proposed strategy in terms of the trial type (i.e., prevention, symptom control, end-of-ife trial) and Phase (0, I, or II) and study population?
• For previously used strategies, is a justification for use of the tool provided?
• For new strategies, are the innovative aspects of new strategies highlighted?
• Will the strategy be generalizable or adaptable to other studies, sites, cohorts, or settings?
• Is the strategy likely to contribute to the field with applicability in both the current environment and in the future post-COVID environment?
• Does the application include a prospective plan to evaluate the performance of the proposed work as well as the effectiveness of the proposed strategy with pre-defined metrics?

Inquiries

Please direct all inquiries to:

Ellen Richmond, MS, GNP-BC
Division of Cancer Prevention
National Cancer Institute
Telephone: 240-276-7043
E-mail: [email protected]