The clinical success of targeted therapies and immunotherapies has stimulated explosive growth in the number of new agents entering clinical trials, and consequently, a substantial increase in the number of possible new drug combination that also will need clinical evaluation. The number of new drugs and drug combinations needing clinical evaluation far exceeds the capacity of the nation?s clinical trial network; therefore, the NCI needs to develop an approach that rapidly evaluates new drugs and new drug combinations and prioritizes the most promising ones for clinical development. The approach must also capture and aggregate the curated data from these trials into a data ecosystem that enables open analysis of the data and exploration of data relationships.The Division of Cancer Treatment and Diagnosis (DCTD) has identified one such approach, which is to use naturally occurring (spontaneous) cancers in dogs as surrogates of human cancers, and it is actively exploring the value of canine cancers for this purpose. Naturally occurring cancers in dogs show clinical and biological similarities to human cancers, and their treatment and medical care are also similar. There are ~70,000 annual cancer cases in companion dogs, creating a patient population of sufficient size for canine clinical trials to evaluate the large number of novel drugs and drug combinations. DCTD has actively pursued several programmatic initiatives to stimulate research into the canine tumor genome and canine tumor immunity.it is critical that the NCI establish an integrated approach for storing, managing, analyzing and relating clinical, biological, molecular and pharmacological results from these trials. For the benefit of other comparative oncology investigators as well as those studying human disease, a publicly-accessible canine data commons is needed. The existing human Genomics Data Commons (GDC)?a unified repository for human cancer sequences and clinical data ? is not available for use with canine data, and DCTD envisions that a canine data commons would house more than genomics and clinical data anyway. CBIIT is developing a next generation, cloud-based data commons called the Cancer Research Data Commons (CRDC) to democratize access and analysis of many types of cancer data, and DCTD seeks to leverage this foundational work to build a commons node for canine cancer data that can be harmonized with other CRDC data for inter-operability and comparison of canine and human cancer data. An Integrated Canine Data Commons (ICDC) will leverage the architecture of CBIIT?s emerging CRDC, using its current Data Commons Framework Services (DCFS), to curate, store, organize, analyze and secure canine cancer data and to relate the canine cancer data to human cancer data as part of an integrated cancer data ecosystem. Although it will leverage the expertise and experience of CBIIT CRDC/DCFS and its FNLCR contractor support, the ICDC is envisioned to create its own data models that harmonize with the human data commons, yet it may have unique data model elements (such as breed of dog and breed-specific reference values, such as multiple reference genomes). Initially, existing data sets of relevant canine cancer data will be sourced, defined and curated in preparation for use during initial system testing. Next, curated canine cancer data will be loaded into the ecosystem and the ecosystem will be tested with relevant, real-world queries and analyses. After prototype development, the system shall be ready for dynamic data collection and opened for use by select, current NCI/COP-sponsored canine clinical trials. This exercise will test the ICDC?s readiness for public launch. After public launch, verification of system performance will be assessed, and incremental updates and improvements will be made to ensure the system has achieved interoperability and usability standards.
