A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NCI 465

Topic

Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for Small Business Innovation Research (SBIR) contract proposals. The specific topic of the solicitation is "Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations". The goal of this solicitation is to address the slow and incomplete accrual of diverse participants in cancer prevention and treatment clinical trials, which hampers drug development and medical progress. The solicitation aims to develop innovative tools that enhance recruitment, retention, and adherence to clinical trials. These tools should improve communication between study staff and participants, build long-term trusted relationships, improve the study participation experience, and reduce the burden of clinical trials for both staff and participants. The solicitation accepts Fast-Track proposals and Direct-to-Phase II proposals. The anticipated number of awards is 3-5. The budget for Phase I is up to $400,000 for up to 12 months, and for Phase II, it is up to $2,000,000 for up to 2 years. Proposals that exceed the budget or project duration may not be funded. This topic aligns with the Cancer Moonshot Blue Ribbon Panel recommendation to establish a network for direct patient engagement. The solicitation is closed, and the application due date was November 14, 2023. More information can be found on the SBIR topic link (https://www.sbir.gov/node/2451721) and the solicitation agency URL (https://sam.gov/opp/aa72581c848947f0b61c15062e604862/view).

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 Page 99 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).