July 27, 2023
- November 23, 2022 - Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required). See NOFO PAR-22-256
National Cancer Institute (NCI)
The purpose of this Notice of Special Interest (NOSI)’s to inform potential applicants of the interest of the National Cancer Institute (NCI) in supporting context specific, pragmatic clinical trials in low- and middle-income countries (LMICs).
Background
In 2020, 70% of the 10 million global estimated deaths due to cancer occurred in low- and middle-income countries (LMICs), as defined by the World Bank. Lacking resources and access to quality care contribute to stark outcomes disparities between LMICs and high-income countries (HICs). Outcomes are driven by systemic weaknesses in healthcare systems, including the diagnostics landscape, high costs of many cancer drugs, supply challenges/interruptions, and complex regulatory pathways. Similarly, surgery is needed for 80% of early-stage cancer patients, and as a palliative measure for a substantial proportion of late-stage cancer patients. However, surgery is only delivered to one in four eligible patients globally due to infrastructure and workforce limitations, as well as lack of affordability, particularly in LMICs. Radiotherapy is indicated for treatment or palliation for about 60% of cancer patients, yet radiotherapy availability is sparse or almost nonexistent in many LMICs due both to issues associated with equipment and human resources needs.
Given the aforementioned resource and infrastructure constraints, service interruptions, limited formularies, and other barriers to cancer care in many LMICs, there is a need to generate evidence-based cancer-related interventions across the cancer control continuum that not only include diverse populations, health systems, and geographic settings, but explicitly take local context and resource and accessibility constraints into consideration.
Research Objectives
NCI encourages applications for pragmatic clinical trials to generate evidence that directly informs decision-making among patients, providers, health systems, communities, and policy makers in LMICs with the goal of improving efficiency, quality, and access for cancer care in resource-constrained settings. The proposed pragmatic trial should (1) be patient-centered, defined as those that involve patients in the trial design and execution to ensure that trial outcomes are relevant and meaningful to patients; (2) be designed to address local disease burdens and health systems and to incorporate input from LMIC stakeholders whose needs, resources, capacities, and priorities are reflected in the study design; (3) include at least one intervention condition and at least one control or comparison condition. Trial designs may be randomized or non-randomized but must be pragmatic. Applications should propose to develop and test new or existing intervention(s) that currently lack adequate evidence and/or are not well established in LMIC settings.
Research foci in LMICs include, but are not limited, to the following:
- Interventions focused on quality improvement, assurance, and control (e.g., strategies to reduce diagnostic delays and wait times for treatment or increase adherence to protocol-directed treatment).
- Interventions that decentralize cancer care and expand the role of primary care in cancer control, including cancer diagnostics, survivorship and supportive or palliative care.
- Interventions that leverage community health workers and/or patient navigation programs to reduce barriers to cancer care, increase treatment adherence, and improve follow-up care.
- Implementation strategies to promote early integration of palliative care for patients with advanced cancer, including home-based palliative care.
Application and Submission Information
This NOSI applies to application due dates on or after October 17, 2023, and subsequent receipt dates through November 18, 2025.
Submit applications for this initiative using the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this Notice.
- PAR-22-256 Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required)
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- For funding consideration, applicants must include NOT-CA-23-078" (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.
Note: Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research (aims) with an NCI program officer listed on this NOSI and/or on the listed funding opportunity announcements well in advance of the chosen application receipt date.
Applications that are submitted in response to this NOSI must include LMIC investigators in the research team.
Non-Responsive Projects
The following aspects/characteristics remain outside the scope of this NOSI.
- Projects lacking LMIC key personnel with substantial involvement in the research activities, where substantial involvement is a minimum level of effort of 1.2 calendar months (10% effort).
- Projects lacking performance site(s) in an LMIC.
- Project not specifically focused on LMIC populations and health system(s).
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:
Scientific/Research Contact(s)
Paul C. Pearlman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5354
Email: paul.pearlman@nih.gov
Financial/Grants Management Contact(s)
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
and Human Services (HHS)
