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340 Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

Fast-Track proposals will not be accepted.

Only Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 3–5
Budget (total costs, per award):
Phase II: $1,500,000 for 2 years

It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 5, 2014 by 4:30 PM ET.

Summary

Mobile and wireless health technologies have grown exponentially in the past few years. Nearly 90% of U.S. adults have a cell phone and smartphone usage is above 60%. The ubiquity of mobile phone use has provided a platform for the delivery of health assessment, monitoring and interventions previously unavailable to health research and practice. The penetration of mobile phone use, even in remote areas, has provided a vehicle for the delivery of health care to people who have little to no other access to care. Wireless sensor technologies also have rapidly expanded in availability and function in the past few years. When paired with mobile and wireless devices, these sensor technologies provide passive, real-time data on a variety of physiological, behavioral, and environmental variables.

The range of health research and clinical practice affected by this mobile/wireless revolution is quite broad. Preventive health assessment and intervention applications for cancer associated behavioral risk factors including smoking, diet, and physical activity have increased dramatically. Mobile and wireless technologies have been employed for medical screening and diagnostic purposes, providing low cost and portable diagnostic tools that can be used in rural and underserved settings. Mobile and wireless technologies also have been used to 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 giving patients the tools 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 and wireless health 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 related 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 requires more evaluation in clinical or behavioral research settings.

This topic encourages validation of mobile/wireless tools to support cancer prevention & control in clinical or behavioral applications. Technologies may include wireless sensors, smartphone applications, behavioral analytics and decision support software or integrated platforms for health assessment, monitoring or intervention delivery. This topic is not intended to support new technology development, but instead to clinically validate recently developed but not yet validated tools, in order to expand evidence of commercial potential and value.

Project Goals

The purpose of this topic is to support validation of mobile/wireless tools (including sensor technologies, smartphone applications, behavioral analytics and decision support software, or integrated platforms) for health assessment, monitoring or intervention delivery which focus on clinical or behavioral cancer prevention and control objectives. In the short term, the topic aims to develop research evidence to support adoption of innovative mobile and wireless health technologies which support cancer prevention, treatment, disease management, or survivorship. Longer term goals are the integration of these technologies into clinical assessment and care, intervention delivery within health systems and accountable care organizations (ACOs), and health research.

Within the context of this topic, “mobile/wireless” health technologies are defined broadly to include any health technologies that wirelessly transmit data and that are intended for portable use. While the focus of these technologies are primarily devices worn on or carried by the individual throughout the day, 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 is 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/wireless screening, diagnostic, assessment or monitoring technologies & methods
  2. Evaluation of the validity of mobile/wireless screening, diagnostic, assessment or monitoring technologies & methods
  3. Evaluation of the efficacy and effectiveness of mobile/wireless 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 proposals submitted in response to this topic.

This topic will prioritize research that will rapidly validate an existing mobile/wireless tools 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 (ROCs). Research evaluating the reliability of the technology is consistent with this topic. For outcome monitoring purposes, assessment of sensitivity to change is also appropriate for inclusion in proposals submitted under this topic.

Validation of mobile and wireless 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), a 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.

Pre-Submission Milestones for Direct-to-Phase II SBIR Technologies:

All proposals submitted under this topic must provide evidence that significant development milestones for a specific mobile/wireless technology or system (detailed below) have already been achieved to demonstrate readiness for a Direct-to-Phase II SBIR 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 a Phase II SBIR with minimal further development other than that required to perform the validation or outcomes research.
    • 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 setting, 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.
  • Test the integration of the technology into the target clinical setting, 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.
Updated: June 24, 2015