Key Dates

Related Announcements

• June 28, 2023 - Notice of Correction to NOT-CA-23-071: Notice of Special Interest (NOSI): Administrative Supplements for Enhancing Recruitment and Retention of Diverse Populations to Cancer Screening, Cancer Prevention and Symptom Management Clinical Trials. See Notice NOT-CA-23-075
• April 27, 2021 - Notice of Special Interest: National Cancer Institute Administrative Supplement Opportunity for Strategies to Optimize Recruitment and Retention of Cancer Prevention and Symptom Management Clinical Trial Participants. See Notice NOT-CA-21-070.
• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Cancer Institute (NCI)

Purpose

The Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI) announces this Notice of Special Interest to encourage current grant or cooperative agreement awardees to apply for administrative supplement funds to support the development of tools and strategies to increase the participation of individuals from all population subgroups who are representative of people for whom the parent grant intervention may be indicated. DCP led or co-led programs appropriate for this opportunity include Cancer Prevention and Control Clinical Trials Grant Program, Cancer Prevention Clinical Trials Network (CP-CTNet), NCI Community Oncology Research Program (NCORP) Research Bases, NCORP Community Sites and NCORP Minority/Underserved Community Sites, Prevention of HPV-related Cancers in HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers Program and the NCI Cancer Screening Research Network: ACCrual, Enrollment, and Screening Sites (ACCESS) Hub. The proposed strategies and tools should be designed to promote inclusion of historically underserved populations in clinical trials - by identifying and reducing enrollment barriers at the organizational, participant, or protocol design level.

Background

Slow participant accrual to cancer screening, prevention, symptom management and quality of life clinical trials with under-representation of participants from historically underserved populations is a longstanding critical challenge that impedes scientific progress and limits generalizability of research findings. Efficacy and safety of interventions for cancer screening, prevention, quality of life and symptom management can differ among population subgroups depending on intrinsic and extrinsic factors, including sex, age, race, genetic background, co-morbidities, ethnicity, lifestyle, living conditions, education level and economic stability. The low rate of enrollment of people from the diverse population subgroups leads to inferences from the results of trials that include participants that represent only part of the affected populations. Thus, people from minority and underserved populations not only miss opportunities to benefit from participation but suffer worse health outcomes due to unanticipated effects of the interventions - which in turn can undermine trust of both the individual and their family in clinical research and the medical establishment.

Known barriers to enrollment include participant reluctance due to research risk concerns or limited awareness of clinical trials along with logistical issues (e.g., transportation, time commitment), organizational factors (e.g., inadequate staffing, limited clinic hours, complex administrative procedures, urban locations), and objectionable protocol design elements (e.g., extra clinic visits, non-standard of care invasive procedures, strict eligibility criteria and agent toxicity). Importantly, the impact of these barriers is magnified by often unintentionally biased interpersonal communication by research staff (e.g., patronization, ethnocentrism) and longstanding institutional practices (e.g., prioritizing academic duties, clinical time requirements, undervaluing clinical trials and cultural competence training and sustained culturally homogeneous staff). Robust strategies are clearly needed to offset these deterrents and help ensure the success of awarded clinical trial programs. Furthermore, reports of rigorous, prospective evaluation of effects of such recruitment and retention interventions would provide reliable guidance for future clinical trial recruitment planning in the advancement of health equity and social justice in cancer care.

Research Objectives

The NCI is providing this opportunity to support supplemental proposals to implement and evaluate promising clinical trial recruitment and retention tools and strategies for cancer screening, prevention and symptom management 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 hypothesis-driven 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. Proposals may include one or more strategies and may be applied to one or more studies or sites. Applications should include a prospective plan for evaluation of the performance of the proposal. Well-defined metrics for evaluating the effects/outcomes of the proposed strategy are also required.Some examples of potential outcomes include percentage of achievement of pre-specified goals for diverse contacts and accrued participants and meeting recruitment and retention milestones in the predicted accrual period as well as results of participant surveys, staff feedback surveys, focus group reports, comparison with past recruitment performance, pre- and post-test results of participant or staff education programs,

Examples of the types of research studies that may be supported through supplemental funding requested and obtained through this NOSI and 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
• Application of artificial intelligence

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;

All applicants are encouraged to discuss their applications with the scientific/research contact listed in this NOSI (below) 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 the funding opportunity announcement used for submission must be followed, with the following additions:

• Application Due Date(s) February 28, 2024, and June 30, 2025, by 5:00 PM local time of applicant organization for possible funding in FY2024, and FY2025, respectively. The Expiration Date of this NOSI is July 1, 2025.
• For funding consideration, applicants must include NOT-CA-23-071 (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.

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

• Only existing awardees of programs supported by the following activity codes/funding mechanisms are eligible to apply: R01, UG1, U01, U24, and U54
• Requests may be for one year of support only.
• 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.
• 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.
• 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-23-071.
• For funding consideration, applicants must include NOT-CA-23-071 (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 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 in order to facilitate efficient processing of the request.

Page limits

The Research Strategy section of the application is limited to 6 pages

Applications responsive to this NOSI are encouraged to address these issues in the Research Strategy:

• 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., screening 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.
  

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.
• Modular and categorical budgets are permitted.
• Requests must reflect the actual needs of the proposed one-year 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.
• The earliest anticipated start date is 8/30/2024. Continuation of this NOSI is contingent upon availability of funds, and the NOSI may be terminated before the current expiration date.

Administrative Review Process

NCI will conduct administrative reviews of applications submitted to their IC and will support the most meritorious applications submitted for consideration, based upon the 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?

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

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

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

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]