NIH/NCI 365: Imaging Informatics Tools and Resources for Clinical Cancer Research

Fast-Track proposals will be accepted.

Direct-to-Phase II will not be accepted.

Number of anticipated awards: 2-3

Budget (total costs, per award):

Phase I: $225,000 for 9 months;

Phase II: $1,500,000 for 2 years

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

Summary

The goal of this contract topic is to support the sustainment and evolution of advanced cancer imaging informatics tools and resources and their broad adoption for clinical research applications through innovative translation and commercialization. The primary focus of this contract topic is on cancer imaging informatics tools and resources that have garnered significant adoption in the cancer imaging research communities.  Imaging informatics tools include computer software tools and platforms to deploy and organize the processing, analysis, and interpretation of medical images to extract and help interpret clinical information, for supporting diagnosis, informing treatment, and providing therapy monitoring and evaluation (using, for example, quantitative imaging tools).  Imaging informatics resources include image and patient data repositories and platforms that provide data, workflow, and a workspace for online research collaboration, evaluation as well as dissemination of informatics tools and resources, and support for population-based research. 

The SBIR contract award will support enhancement and ongoing support of advanced cancer imaging informatics tools and resources to address Big Data opportunities and challenges and target critical unmet needs for validated clinical decision support tools and resources towards meeting precision medicine goals in cancer clinical research.

Project Goals

The primary goal of the proposed SBIR contracts is to develop and implement solutions for sustained support for the advanced development, evolution, and broad adoption of cancer imaging informatics tools and resources. Successful solutions should address the following challenges: 1) Imaging informatics tools and resources developed in the academic research environment are typically not fully developed in terms of usability and documentation, or their interoperability with other tools and data types. 2) Due in part to the continuous development nature of the funded research projects, few imaging informatics tools and resources are comprehensively evaluated for specific clinical applications and translated to suitable commercial products for broader adoption.  3) The overall lack of solutions for sustaining support and evolution for these tools and resources has limited the development teams’ ability to evolve these tools and resources to continuingly meet user needs.

The overall scope of proposed funding approach includes the entire spectrum of cancer imaging, extending from microscopic, pathological imaging to in vivo clinical imaging for all phases of cancer clinical research. Offerors will be expected to formulate and execute well designed project plans with clearly defined milestones that will eventually lead to commercially viable solutions for 1) sustained development and evolution of cancer imaging informatics tools and resources and 2) their broad adoption in clinical cancer research. 

Awardees will deliver enhanced services such as training, documentation, and help desk support that improve the overall usability, user adoption, and evaluation of the tools and resources for commercial translation. They are expected to develop and implement necessary technical solutions and business processes for hosting the selected cancer imaging informatics tools and resources and providing other necessary user support services for engaging user communities to promote broad adoption. They will enhance the tools and resources to meet evolving user needs.  Early phase R&D such as the development of novel imaging acquisition schemes, new image analyses algorithms or software is not responsive to the solicitation.

Phase I Activities and Deliverables

The Phase I proposal is expected to identify roadblocks and provide innovative yet feasible solutions necessary for commercial translation of the targeted cancer imaging informatics tools and resources. The offerors are required to demonstrate prior experience with the cancer imaging informatics tools and resources addressed in the proposal.  Example of such proposals include improvements to the informatics tools and resources necessary for meeting key usability and interoperability metrics to enable phase II implementation on commercially viable platforms.  Phase I work is expected to develop use indications for the underlying cancer imaging informatics tools and resources, performance requirements necessary for supporting clinical research and applications goals, as well as critical hardware and software system specifications of informatics platforms for Phase II deployment of the underlying informatics tools and resources.

Key deliverables will be:

• Design specifications for enhancing image informatics tools and resources to support required usability, data and tools interoperability, patient data protection, as well as other features required for supporting phase II commercialization,
• Clear documentation of the tools and resources, and
• An early phase product prototype and detailed project plan for phase II implementation, as well as a demonstration of the prototype to NCI (using funds set aside for this purpose).

An example might include a phase I proposal to improve existing open imaging informatics tools and resources for use in drug trials or co-clinical trials that support the requirements of traceability and reproducibility for FDA filing.

Phase II Activities and Deliverables

• Phase II projects will be expected to implement requirements identified in Phase I, and launch a commercially-viable prototype cancer imaging informatics product targeted to the usage defined in Phase I. The system design process should encourage user-user and user-developer interactions for evaluation and further evolution of the informatics tools and resources and associated documentation. 
• The offerors are expected to develop and implement a business process that will promote broad adoption of the tools and resources by actively engaging the user communities; seek support and undertake efforts to achieve recognition, certification, and adoption by clinical trials groups and professional societies; and eventually engage with regulatory agencies such as the FDA for adoption in drug trials and co-clinical trials.  The business process should also address plans for long term sustainability, such as sustained hosting of tools, data, training, and associated resources, as appropriate. 
• The proposed product implementation should also address the unique requirements for clinical application of imaging informatics tools and resources, including legal, financial, and marketing complexities associated with the development and release of the targeted commercial product(s).

Key deliverables for phase II projects will be enhanced image informatics tools and resources that are evaluated by key user groups and are appropriately validated for use in a clinical cancer research setting.