Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will be accepted.
Number of anticipated awards: 3-5
Budget (total costs, per award):
Phase I: up to $400,000 for up to 12 months
Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Slow and incomplete accrual of diverse participants to cancer prevention and treatment clinical trials continues to hamper the
rate of drug development and medical progress. A study in 2014 reported that 1 in 4 cancer clinical trials were terminated
early with 1 in 10 being terminated for poor accrual. A recent study found worsening underrepresentation of patients from
racial and ethnic minority groups in Phase 1 cancer clinical trials between 2000 and 2018. There are no easy solutions to
solving accrual challenges. Retention of subjects enrolled in trials can also be a challenge, especially in long-term or
demanding trials. Recruitment, retention, and adherence obstacles are magnified in cancer prevention trials due to eligible
participants being at varying levels of cancer risk, generally asymptomatic and active, lacking the motivation of a patient
with a cancer diagnosis, and finding non-standard-of-care procedures more objectionable. Many NCI networks provide
program and protocol-specific recruitment manuals, tools, and educational resources. However, more innovative,
generalizable tools that increase accrual of diverse participant populations and are based on empirical evidence are mostly
lacking. This solicitation has the potential to enhance clinical trials recruitment, retention, and adherence through the
development of tools that could be used across the cancer continuum. The goal of these tools is to enhance communication
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between study staff and participants, build long-term trusted relationships, improve the study participation experience, and
reduce the burden of clinical trials to both staff and participants.
This topic is aligned with the Cancer Moonshot Blue Ribbon Panel recommendation to establish a network for direct patient
engagement (A).
