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NIH/NCI 465 – Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations

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 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).

Project Goals

The goal of this concept is to solicit proposals to advance the development of tools to improve clinical trial recruitment. The tool may be participant-facing, clinic-facing, or both. If clinic-facing, the tool should help identify recruitment barrier(s) and present targeted options for effective recruitment strategies to overcome these barrier(s), help improve staff communication and relationship-building skills, integrate with electronic medical records, and allow for tracking of screening efforts. If the tool is participant-facing, it should be designed to engage potential participants, help them better understand details of a given trial, and be adaptable for different trials. Some of the best practices for recruitment and retention that are relevant to tool development include: (1) Consider the patient point of view and identify and address reasons why eligible patients decline trial participation. (2) Simplify informed consent documents and enhance personal communication during the informed consent process, including clarifying possible financial liability the patient may incur by participating in the trial. (3) Educate patients and the community, including community providers, about clinical trials using culturally appropriate material. (4) Use smart devices, social media, patient registries, and electronic databases to identify potential participants, notify providers, and boost recruitment and retention. (5) Provide access to peer mentors (other patients who have participated in a clinical trial) and patient navigators for those patients identified as in need of additional support. (6) Increase awareness and provide easy access to information on all ongoing clinical trials.

The tools should incorporate these best practices and may:

  • Develop and test culturally sensitive participant educational tools/interventions that support varied communication preferences reducing bias (e.g., written, visual, etc.).
  • Develop and test provider-based tools to facilitate identification of and discussion with potential participants.
  • Facilitate understanding costs associated with clinical trials participation.
  • Integrate with smart devices, social media, patient registries, and electronic medical records.
  • Enhance the consenting process.
  • Enhance study adherence through interactive participant and/or study-team engagement.
  • For retention, provide a two-way platform for participant communication to study team and support conveying team information to the study participants.

Phase I Activities and Deliverables:

  • Phase I is to develop proof-of-concept or prototype tools, technologies, or products for monitoring and enhancing cancer prevention, treatment, and control clinical trials recruitment and retention. 
  • Develop and characterize a prototype tool/technology and demonstrate that the tool addresses specific recruitment and/or retention concern(s).
  • Specify and justify quantitative milestones that can be used to evaluate the success of the tool or technology being developed.
  • Provide a proof-of-concept SOP for the tool or technology. 
  • Consider human subjects protection compliance. 
  • Demonstrate feasibility and usability with a pilot user testing. Provide a report on the results of the first round of usability testing and the approach to modify the platform based on this user feedback. Offerors shall provide a technical evaluation and quality assurance plan with specific detail required for use. 
  • Demonstration that the tool, technology, or product can be adapted to multiple clinical trials at a price point that is compatible with market success and widespread adoption by the clinical research community. 
  • Present Phase I findings and demonstrate the functional prototype system to an NCI evaluation panel via webinar. 

Phase II Activities and Deliverables:

The goal of Phase II is an optimized commercial resource, product, or tool for cancer prevention, treatment, and control clinical trials recruitment and retention. 

  • Enhance, test, and finalize the tool with refinement of SOPs to allow for user friendly implementation of the tool, technology, or product by the target market including human subjects’ protection compliance. 
  • Provide a report that synthesizes feedback from all relevant categories of end-users (such as physicians, oncologists, nurses, patients, and patient navigators) and summarizes the modifications made to the platform after each round of usability testing.
  • Validate scaled up tool, technology, or product. Specifically, demonstrate the utility, of the tool, technology, or product across clinical trials. 
  • Develop systems documentation and user guides to facilitate commercialization, including citation and details of how systems align with current regulations and best practices in user-centered design, interoperability, and protection of privacy and confidentiality of information. 
  • Present Phase II findings and demonstrate the system via a webinar at a time convenient to the offeror and NCI program staff.

 

Receipt date: November 14, 2023, 5:00 p.m. Eastern Standard Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

View the full PHS2024-1 Contract Solicitation.

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