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).
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.
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.