Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 3-4 Budget (total costs, per award): Phase I: up to $400,000 for up to 9 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
A large number of NCI funded clinical trials fail to meet their accrual goals which leads to delays, early termination, or inability to draw conclusions at trial completion due to loss of statistical power. A study in 2014 reported that 1 in 4 cancer clinical trials were terminated early with 1 in 10 being terminated for poor accrual. There are no easy solutions to solving accrual challenges. Retention of subjects enrolled in trials can also be a challenge. NCI provides various educational resources and tools to support and enhance participant accrual through portals like AccrualNet. However, most of these resources are limited to educating the study team on good practices to enhance accrual. Tools that could be either clinic-facing or participant-facing or both and that are based on empirical evidence and have been shown to increase participant accrual and retention are mostly lacking.
This solicitation has the potential to enhance clinical trials recruitment and retention by developing tools that could be used across NCI clinical trials networks and beyond. The goal of these tools is to enhance communication between participants and study staff and reduce the participant burden of traveling to the clinic when virtual communication is sufficient.
Project Goals
The goal is to solicit proposals to advance the development of tools for clinical trials recruitment, retention, or both. The tool could be clinic-facing or participant-facing or both. If clinic-facing for recruitment, it should help identify protocol barriers to recruitment and present options for addressing the challenge(s), effective recruitment strategies, potentially integrate with electronic medical records, and allow for tracking of screening efforts. If clinic-facing for retention, it should enhance patient engagement, potentially integrate with electronic medical records, and allow for tracking of retention efforts. If participant-facing for recruitment, it should be designed to engage potential participants, help them understand details of a given trial, and be easily adaptable for different trials. If participant-facing for retention, it should be designed to engage enrolled participants, help them adhere to protocol requirements and communicate with clinic staff in an effective and efficient manner, and be easily adaptable for different trials. Preference will be given to projects that are easily adaptable between trials.
The best practices for recruitment and retention that are relevant to tool development include [Denicoff AM et al. (2013) J Oncol Pract. 9(6): 267-76]:
1) Consider the patient point of view of potential research, including potential barriers, when reviewing and implementing trials. Patient advocates could support this effort.
2) Identify and address reasons why eligible patients decline trial participation.
3) 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.
4) Educate patients and the community, including community providers, about clinical trials, using culturally appropriate material.
5) Use smart devices, social media, patient registries, and electronic databases to identify potential participants, notify providers, and enhance recruitment and retention to prevention, treatment, quality-of-life, survivorship, and rare-cancer studies.
6) 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.
7) Increase awareness and provide easy access to information on all ongoing clinical trials.
The tools should incorporate these best practices and should
• Develop and test culturally sensitive participant educational tools/interventions that support varied communication preferences (e.g. written, visual etc.).
• Develop and test provider-based tools to facilitate 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 (gamification).
• For retention, provide a platform for participant communication to study team and provide information to the study participants.
Phase I Activities and Deliverables
The goal of 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. Activities and deliverables include:
• 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. Deliverables and activities include:
• 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.
