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The purpose of this Funding Opportunity Announcement (FOA) is to support research using advanced technologies (e.g., bio-chips, microfluidics, and mobile technologies) to develop novel point-of-care (POC) devices and implement existing technologies in clinical settings with a goal to guide diagnostic and therapeutic efforts for the heart, lung, blood and sleep disorders. Applicants are encouraged to form a multidisciplinary team/network (i.e., from technical to clinical expertise) to develop devices that will significantly empower patients, physicians, and clinical researchers to better manage or treat HLB and sleep disorders.
Applicants should describe technical approaches, methodologies, and plan to develop and implement their POC devices that will significantly improve disease management and/or treatment. Applications should have all relevant details including quality control and assurance, standards for samples, handling, and testing. Related previous experience and qualifications of the team members should be well described. Once the POC tool/technology/test has been developed and validated, applicants will be expected to test the feasibility of the product in ongoing (or otherwise) heart, lung, blood and sleep clinical studies. Applications may also need to describe how to interpret the testing results as well as relevant bioinformatics and/or wireless technological component to link the POC test data with other relevant patient data (e.g., data in Electronic Health Records). This will enable the rapid sharing and synchronization of data for treatment at the POC. It is expected that commercial products or tools will be developed for use in the clinical setting at the POC as a result of this program.
POC technologies are becoming increasingly valuable tools in improving or enhancing the diagnosis of several conditions including congestive heart failure, acute coronary syndrome, coagulopathy and asthma. Major benefits such as faster time to intervention have been demonstrated when the results of POC testing are utilized in conjunction with Electronic Health Records or mobile technology, and when combined with goal directed therapy. Utilization of POC technology allows for:
Based on the benefits listed above, these technologies have the potential to play a pivotal role in personalizing medicine, improving healthcare delivery, and, ultimately, reducing healthcare costs. While many of these tools are being developed for clinical application, it is also possible that some of the existing technology could enhance the research enterprise by being used “onsite” for clinical research and trials. Additional benefits of POC-related tools and technologies in clinical research include: easier recruitment, baseline, and follow-up measurements, expedited patient ascertainment and analysis, more rapid dispensation of interventions, better quality control and monitoring of study compliance. Utilization of POC technology could also allow for research participants to be enrolled in less sophisticated research environments and remote, low-resource locations.
Specific Areas of Research Interest:
Projects that address a specific and well-characterized clinical need will be considered of high potential impact. The technologies developed with funding through this FOA are expected to be integrated systems or, if they are novel components, be easily integrated into existing systems. Proposed tools or technologies should interoperate and communicate with existing health information technology systems as appropriate. Some other technical features that are expected are the following: reliability, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, inclusion of software to support decision-making, and consideration of power consumption. Ideally, systems will integrate information from multiple sensors, appropriate clinical information, and ambient data such as temperature or global position. Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate. In addition, global health concerns, improved access to underserved areas, and cost-effectiveness should be highlighted.
Research examples include, but are not limited to:
Applicants are encouraged to collaborate with federally funded programs such as the NCATS Clinical and Translational Science Awards (CTSAs), the NIBIB Point-of-Care Technologies Network (POCTRN), the NICHD Medical Rehabilitation Research Infrastructure Network, the NIH Basic and Behavioral & Social Science Opportunity Network (OppNet), the NIH National Centers for Biomedical Computing (NCBC), the Agency for Healthcare Research and Quality (AHRQ) Practice Based Research Networks (PBRNs), the AHRQ Patient Safety Network (PSNet), the AHRQ Evidence-based Practice Centers (EPC), and the AHRQ Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. If collaborating with such a program, applicants should describe how the collaboration would enhance performance and productivity to explore, develop, and integrate tools and technologies for supporting clinical trials. Applicants are advised to provide a letter of agreement that identifies the level of support from the Principal Investigator or Program Director of those centers.