The CTSA Program high priority research areas to be considered for supplemental funding responsive to NOT-TR-18-022 in FY18 include, but are not limited to, the following:
Planning / Pilot Grants to support:
• Projects intended to develop and test models of care for Opioid Use Disorders within medical settings including primary care, emergency departments, and neo-natal units. Partnerships between CTSA Program hubs and affiliates in rural areas of the country most impacted by the opioid epidemic including the North East, the Appalachian Region, and New Mexico, as well as partnerships with NIDA Clinical Trials Network Nodes (https://www.drugabuse.gov/about-nida/organization/cctn/ctn/network-organization/nodes) in these regions are of strong programmatic interest.
• Projects intended to be responsive to the CTSA Program Collaborative Innovation Suite of Awards funding opportunities [PAR-18-591 (U01) and PAR-18-245 (R21), PA-16-328 (Admin Supplements)].
• Educational and/or training: Development, demonstration, and/or dissemination of educational and/or training materials and/or resources that would impact the translational research workforce. Projects are encouraged to use a dissemination format that would maximize the reach and impact of the educational and/or training materials. This may include open educational resources such as online courses (massive open online course – MOOC) or development of materials that could be disseminated through an institution’s learning management system. Any proposed delivery of in-person education and/or training should have maximal reach and impact across the consortium and consider options for videocasting to enhance attendance. Workshops may also be proposed but must be held during the budget period of the supplement.
Research Software Applications:
• Applications to purchase, license, or upgrade a single item of expensive, specialized, commercially available software for research management or research data warehouses. Types of applications supported include but are not limited to commercial clinical trial management applications and data ware house solutions. Enthusiasm will be higher for applications that disseminate applications across the entire health system.
Software Messaging Standards and Balloting:
• The use of a Single IRB will require bidirectional communications at both the study level (reviewing, relying, protocol, COI) and as well as the study conduct level (SAE, AE, Study deviation). To avoid, the need for double data entry of data messaging standards that facilitate interoperability are required. Enthusiasm will be higher for projects that facilitate the electronic messaging protocols, balloted through a Standards organizations such as HL7.
Rare Diseases Research:
• Novel informatics-based approaches for early diagnosis of rare diseases. Examples of informatics-based approaches for early diagnosis of rare diseases include but are not limited to:
• Analyzing electronic health records in large patient databases using natural language processing and/or artificial intelligence methods;
• Development of machine-assisted decision support based on constellation of symptoms and differential diagnosis for rapid identification and escalation of patients with “warning signs”
• Exploration into novel technologies for data capture and patient assessment methods. Examples of novel approaches for data capture/patient assessment in rare diseases include but are not limited to:
• Telemedicine-enabled remote clinical assessments of patients by rare disease expert clinicians;
• Telemedicine-enabled linking of primary care doctors to rare disease expert clinicians for remote consultations;
• Testing of wearable devices for clinical data collection from patients in their own environment
• Applications to purchase or upgrade a single item of expensive, specialized, commercially available instruments or integrated systems. The minimum award is $100,001. The maximum award is $2,000,000. Types of instruments supported include, but are not limited to: X-ray diffractometers, mass and nuclear magnetic resonance (NMR) spectrometers, DNA and protein sequencers, biosensors, electron and light microscopes, cell sorters, and biomedical imagers. Enthusiasm will be higher for applications that will facilitate the introduction of advanced cutting-edge instrumentation technologies, share the instrumentation across multiple hubs, and would contribute to transforming the translational science process.