NIH/NCI 342: Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

Fast-Track proposals will not be accepted.

Direct to Phase II proposals will be accepted.

Phase I proposals will not be accepted.  Only Direct to Phase II proposals will be accepted.  Only a small business concern that has already performed Phase I stage-type research through other funding sources may submit a proposal under this topic.

Number of anticipated awards: 2-3

Budget (total costs, per award): Phase II: up to $1,500,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Mobile health technologies have grown exponentially in the past few years. The ubiquity of mobile phone use provides a platform for health assessment, monitoring and interventions previously unavailable to health research and clinical practice. The penetration of mobile phone use, even in remote areas, provides a vehicle for health care delivery to individuals with limited access to care. Wireless sensor technologies have also rapidly expanded in availability and function in the past few years. When paired with mobile devices, these sensor technologies provide real-time data on a variety of image-based, physiological, behavioral, or environmental variables. 

The range of health research and clinical practice affected by this technology revolution is quite broad. Preventive health assessment and intervention applications for cancer associated behavioral risk factors have increased dramatically. Mobile technologies have been developed for medical screening and diagnostic purposes, providing low cost and portable diagnostic tools for use in rural and underserved settings. Mobile technologies have also been used to support cancer survivorship care and improve chronic disease management for cancer risk factors such as obesity and diabetes, allowing healthcare providers to more intensively monitor patient status and intervene as needed while providing patients a resource to more effectively self-manage their disease. 

The NCI Division of Cancer Control and Population Sciences aims to reduce risk, incidence, and deaths from cancer, as well as enhance the quality of life for cancer survivors. Emerging mobile technologies provide an opportunity to support innovation and progress towards NCI’s mission of cancer prevention & control by 1) improving quality or access & reducing cost or burden of screening, diagnostic, treatment and follow-up care for cancer and associated chronic diseases; and 2) improving lifestyle intervention efficacy and scalability for cancer related behavioral risk factors. The number of mobile and wireless health tools grows each year, but the majority of these tools have been inadequately validated in clinical research and practice. Adoption of these technologies in support of cancer treatment and survivorship requires more evaluation in clinical and behavioral settings. This topic is not intended to support new technology development, but instead to clinically validate promising but insufficiently tested tools for cancer prevention & control.

Project Goals

The purpose of this topic is to support validation of mobile technologies for clinical assessment, screening, diagnostics, monitoring or intervention delivery focused on cancer prevention, and control objectives. Examples of technologies may include monitoring or diagnostic sensors & paired smartphone applications, cancer treatment or survivor care planning & remote monitoring systems, behavioral analytics and decision support systems, or intervention delivery systems.  In the short term, the topic aims to develop research evidence to support adoption of innovative mobile technologies which support cancer prevention, treatment, disease management, or survivorship. Longer term goals are the integration of these technologies in clinical assessment, care & intervention delivery within health systems, accountable care organizations (ACO), and health research.

Within the context of this topic, "mobile" health technologies are defined broadly to include any health technologies that wirelessly transmit data and that are intended for portable use. The early focus of these technologies has primarily been devices worn on or carried by the individual throughout the day. However, devices that provide a level of portability not previously available (e.g. smaller and more portable version of a diagnostic scanner that transmits data wirelessly to the healthcare provider) is consistent with the scope of this initiative.

As noted previously, this topic in not intended to support the development of new technologies. Some additional programming may be required to customize or integrate the technology into the target clinical, health system, or related software environments, but these efforts should be sufficiently limited to retain a focus on validation and expanded evidence of commercial potential and value for health assessment or outcomes.

Responses to this topic are expected to address one or more of the following areas of mobile/wireless health research;

1. Evaluation of the reliability of mobile screening, diagnostic, assessment or monitoring technologies & methods.
2. Evaluation of the validity of mobile screening, diagnostic, assessment or monitoring technologies & methods.
3. Evaluation of the efficacy and effectiveness of mobile technology and systems for behavioral analytics, clinical decision support, or intervention delivery.

Although extension of existing usability, acceptability, and feasibility of the mobile/wireless health tool may be considered as secondary research questions, they should not be the primary objectives of applications in response to this topic.

This topic will prioritize research that will rapidly validate existing mobile technologies in clinical care & monitoring, clinical decision support or intervention applications. It is anticipated that the clinical screening, diagnostic, assessment, and monitoring technologies will provide the "gold standard" comparator for the new mobile or wireless tool being evaluated, but additional clinical measures may be needed to validate the new tool. However, in some instances, novel measures may not directly translate to existing clinical “gold standard” measures/technologies, and alternative validation approaches may be required. Validation analyses could include but are not limited to agreement rates, sensitivity/specificity, and receiver operating curves (ROC). Research evaluating the reliability of the technology is consistent with this topic. For outcome monitoring purposes, assessment of sensitivity to change are also consistent with this topic.

• Validation of mobile technologies and systems for intervention delivery or decision support are particularly encouraged. Dependent on the research question and technology under evaluation, research designs may include randomized controlled trials (RCTs), series of single case designs, optimization designs (e.g. factorial, sequential) or quasi-experimental approaches such as interrupted time series and stepped-wedge designs. Projects that integrate and automate ongoing validation and/or outcomes evaluation (e.g. automated RCTs) in the commercial product are particularly encouraged. For additional information on evaluation of mHealth technologies please see (http://www.ajpmonline.org/article/S0749-3797(13)00277-8/abstract). Primary clinical or behavioral outcomes may be supplemented with cost-effectiveness analyses where appropriate.

Milestones for Direct-to-Phase II Technologies

All proposals submitted under this topic must provide evidence that specific mobile technology or systems development milestones have been achieved to demonstrate readiness for a Direct-to-Phase II contract. These milestones will be evaluated in addition to standard review criteria for all submissions.

1. Provide evidence that a working prototype, including all major functional components of the technology, is ready for formal validation in Phase II with minimal further development other than that required to perform the validation or outcomes research.
   
   a. Products in beta version are particularly appropriate for this effort although recently released commercial products that do not have adequate validity or efficacy support are also encouraged.
2. Provide documentation that the product to be evaluated has been developed based on theory and/or empirical evidence.
3. Present evidence that appropriate focus groups, interviews, cognitive or user testing with potential end-users of the device/software tool, etc. have been conducted to demonstrate that the feasibility, acceptability, and usability of the product have been established.
4. Provide evidence that an established project team with appropriate expertise for the scope of work is in place to advise and support the small business on Phase II activities and outcomes. This team should include, but will not be limited to, personnel with training and research experience in clinical or intervention design, implementation, and statistical methods for validation/evaluation as appropriate for the proposed project.

Phase II Activities and Deliverables

• Provide documentation that the established project team with appropriate expertise for the scope of work is in place to advise and support the small business on Phase II activities and outcomes. This team should include, but will not be limited to, personnel with training & research experience in clinical trial or intervention design, implementation, and statistical methods for validation/evaluation as appropriate for the proposed project. Provide a report outlining team member credentials, specific project roles, and timelines for performance.
• Evaluate specific IT customization requirements to support hardware, software, or communications system integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the specific IT customization requirements and timelines for implementation.
• Evaluate, enhance as necessary and provide documentation that the technology and communications systems maintain compliance with HIPAA, data security, privacy, and consent management protocols as required for the proposed solution.
• Evaluate, enhance as necessary, and provide documentation that data systems, APIs & wireless transmissions for all clinical, laboratory, or behavioral measures sent or received adhere to common data elements standards (e.g. HL7, SNOMED, LOINC, etc.) where available to facilitate data sharing and system integration.
• Evaluate, enhance as necessary, and provide a report detailing communication systems architecture and capability for data reporting to patients/subjects, care providers, clinicians/researchers, electronic medical records, and health surveillance systems as appropriate for the proposed technology solution.
• Test the integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the results of system testing and timelines for problem mitigation.
• Develop user support documentation to support all applicable potential users of the technology, including but not limited to patients/consumers, family/caregivers, and providers. Provide a report documenting user support resources, including but not limited to, links to online resources and copies of electronic or paper user support resources as appropriate.
• Prior to evaluation, provide a final report of the research plan including at a minimum:
  
  • Appropriate human subjects protection / IRB submission packages and documentation of approval for your research plan.
  • Final study design including aims, participant characteristics, recruiting plans, inclusion and exclusion criteria, measures, primary and secondary endpoints, design and comparison conditions (if appropriate), power analyses and sample size, and data analysis plan.
  • Publication plan outlining potential research and whitepaper publications resulting from the research, including anticipated lead and co-author lists.
• Provide study progress reports quarterly, documenting recruitment and enrollment, retention, data QA/QC measure, and relevant study specific milestones.
• Prepare a tutorial session for presentation at NCI and/or via webinars describing and illustrating the technology and intended use.
• Include funds in budget to present Phase II findings and demonstrate the technology to an NCI evaluation panel.
• In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest.

In the second year of the contract, provide the program and contract officers with a letter(s) of commercial commitment.