grant

Clinical Translation and Validation Core

Organization JOHNS HOPKINS UNIVERSITYLocation BALTIMORE, UNITED STATESPosted 30 Sept 2021Deadline 31 May 2027
NIHUS FederalResearch GrantFY2025AI algorithmAI systemAI technologyAdvanced DevelopmentAdvertisingAgingAmbulatory CareAmentiaAreaArtificial IntelligenceCaringClinicClinicalClinical ResearchClinical StudyCognitionCognitiveCognitive DisturbanceCognitive ImpairmentCognitive declineCognitive function abnormalCollaborationsCommunitiesComputer ReasoningConsentDataData AnalysesData AnalysisData CollectionDementiaDevelopmentDevelopment PlansDevicesDisturbance in cognitionDocumentationEligibilityEligibility DeterminationEngineeringEnsureFutureGeriatricsGoalsHealth Care TechnologyHealth TechnologyHomeHuman Subject ResearchIRBIRBsImpaired cognitionInstitutional Review BoardsInterventionInvestigatorsLaboratoriesLeadershipLong-Term CareMachine IntelligenceMaintenanceMeasurementMedical centerMentorshipMethodsMinority RecruitmentMonitorNursing HomesOlder PopulationOutcomeOutpatient CarePerformancePhysical FunctionPilot ProjectsPreparationPrimary CareProceduresProtocol ScreeningRegistriesRegulatory approvalResearchResearch DesignResearch PersonnelResearch ResourcesResearchersResourcesSafetyScientistSiteStudy TypeTechnologyTestingTrainingTranslational ResearchTranslational ScienceTranslationsTrustUniversitiesValidationWorkartificial intelligence algorithmartificial intelligence technologyclinical trainingclinical translationclinical validationclinically translatablecognitive dysfunctioncognitive losscollaboratorydata interpretationdesigndesigningdevelopmentalexperienceextended carefeasibility testingfrailtygeriatric medicinehomeshuman subjecthuman subject protectioninterestnursing homeolder adultolder adulthoodolder groupsolder individualsolder personoutpatient treatmentpilot studypreparationsprogramsprotocol developmentprototyperecruitrecruiting minoritiesregulatory authorizationregulatory certificationregulatory clearanceresilienceresilientskillsstudy designsynergismtech developmenttechnology developmenttechnology implementationtechnology validationtranslationtranslation researchtranslational investigationvalidations
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Full Description

The Johns Hopkins University (JHU) Artificial Intelligence (Al) and Technology Collaboratory (AITC) proposes
a Clinical Translation and Validation Core that aims to cultivate and support cutting edge Al prototype testing

and exploratory studies that are needed to develop crucial larger scale and confirmatory pilots in order to

advance the development of effective Al technologies to facilitate independence in older adults. This core is

designed to serve as a hub and a clinical laboratory for innovators to validate prototypes and undertake

rigorous feasibility testing for the Al algorithms and technology devices in clinical and "real-world" settings. The

specific aims of the Clinical Translation and Validation Core are 1) To provide state-of-the-art scientific (Clinical

and Engineering) expertise and work with the administrative core to facilitate soliciting proposals and

identifying and selecting Al approaches or technologies to be clinically validated in the Collaboratory or our

partner sites; 2) To develop and maintain a research registry with emerging Al approaches or technologies to

be validated in clinics and identify clinical researchers (and their clinical studies) and other stakeholders

interested in validating Al algorithms or technologies in their clinics or other real-world settings; 3) To provide

the AITC investigators identified in aim 1, with mentorship and training in all aspects of human subjects'

research, including study conceptualization, study design and outcomes, definition of interventions,

measurement, data analysis, protocol development and implementation, regulatory approval, quality

assessment, and standard operating procedures related to aging, dementia and the maintenance of

independence; 4) to provide intellectual leadership necessary to identify and match Al researchers with clinical

research investigators that are best suited to successfully validate prototypes and undertake rigorous feasibility

testing for the artificial intelligence algorithms and technology devices in both clinical and "real-world" settings;

and 5) to facilitate the transition of successful prototypes into clinical studies in collaboration with the

leadership of the Pilot Cores (Aging and AD) as well as all other cores. To achieve these goals, the core is led

by an Al and technology development experienced investigator partnered with a Geriatrics Clinician Scientist

with expertise in translational research focused on physical and cognitive decline in older adults. This balanced

leadership will facilitate the development, implementation, and conduct of prototype development and testing in

this core. A highly skilled and experienced research program manager with expertise in minority recruitment

and the measurement of frailty and mobility will facilitate the completion of these aims. These aims will be

carried out in collaboration with the leaders of all other cores. Additional resources are provided by the JHU

Institute of Clinical and Translational Research, which will help to ensure optimal study design, implementation,

measurement, and interpretation of results, and Fast Forward, a translationally-focused unit at JHU, will

facilitate health technology development that focuses on using Al to maximize independence in older adults.

Grant Number: 5P30AG073104-05
NIH Institute/Center: NIH

Principal Investigator: Rama Chellappa

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