U54DE035413

COLLABORATIVE FOR RESEARCH TO ADVANCETMD EVIDENCE (CREATE) - TEMPOROMANDIBULAR DISORDERS (TMDS) INVOLVE COMPLEX AND POORLY UNDERSTOOD PATHOPHYSIOLOGICAL PROCESSES, LIMITING PREVENTION, DIAGNOSIS, PROGNOSIS AND THE DEVELOPMENT OR APPLICATION OF EFFECTIVE, EVIDENCE-BASED TREATMENTS. THE COLLABORATIVE FOR RESEARCH TO ADVANCE TMD EVIDENCE (CREATE) AIMS TO ADDRESS THESE CRITICAL GAPS THROUGH A BIDIRECTIONAL APPROACH THAT INTEGRATES CLINICAL AND PRECLINICAL RESEARCH TO IDENTIFY UNDERLYING MECHANISMS, DEVELOP PERSONALIZED THERAPIES, AND IMPROVE PATIENT OUTCOMES. THE ADMINISTRATIVE CORE (AC) WILL MANAGE CREATE’S SCIENTIFIC, ADMINISTRATIVE, AND OPERATIONAL FUNCTIONS, ENSURING ALIGNMENT WITH NIH GOALS, STANDARDIZING DATA COLLECTION ACROSS SITES, AND ADHERING TO FAIR PRINCIPLES FOR DATA AND BIOSPECIMEN MANAGEMENT. THE BIOINFORMATICS AND DATA SCIENCE CORE (BDSC) WILL EMPLOY THE LATEST AI AND MACHINE LEARNING TECHNIQUES TO ANALYZE MULTI-MODAL DATA, IDENTIFY TMD SUBTYPES, IMPLICATE THERAPEUTIC TARGETS, AND ESTABLISH FRAMEWORKS SUCH AS COMMON DATA ELEMENTS (CDES) AND ONTOLOGIES TO ENHANCE DATA INTEGRATION. THE OUTREACH, TRAINING, AND EDUCATION CORE (OTEC) WILL EXPAND THE TMD RESEARCH AND CLINICAL WORKFORCE, FOSTER COLLABORATION WITH STAKEHOLDERS, AND ORGANIZE BIANNUAL PUBLIC WORKSHOPS TO DISSEMINATE FINDINGS AND GUIDE THE COLLABORATIVE’S EFFORTS. AT THE HEART OF CREATE IS THE DEEP PAIN PHENOTYPING PROJECT, A LARGE-SCALE LONGITUDINAL STUDY INVOLVING 1,000 TMD PATIENTS AND 300 AGE-MATCHED CONTROLS ACROSS MULTIPLE US CLINICAL CENTERS, DESIGNED TO ENABLE IDENTIFICATION OF TMD SUBTYPES THROUGH STANDARDIZED ASSESSMENTS AND MECHANISTIC DEEP PHENOTYPING. THE IDENTIFICATION OF TMD SUBTYPES WITH HIGH RELIABILITY AND SELECTIVITY WILL FACILITATE DIAGNOSIS AND PROGNOSIS AND FUTURE CLINICAL TRIALS, AND MAY SUGGEST MORE EFFECTIVE PREVENTIVE AND THERAPEUTIC STRATEGIES. THE CLINICAL DATASET WILL ALSO INFORM REVERSE TRANSLATION TO PRECLINICAL STUDIES TO FURTHER ELUCIDATE MECHANISMS AND VALIDATE THERAPEUTIC TARGETS. BY LEVERAGING THE EXPERTISE OF A DIVERSE, MULTIDISCIPLINARY TEAM, CREATE SEEKS TO BRIDGE THE GAP BETWEEN CLINICAL DATA AND PRECLINICAL INSIGHTS, PAVING THE WAY FOR IMPROVED DIAGNOSTICS, TREATMENTS, AND PATIENT CARE IN TMDS.

University Of Pittsburgh - Of The Commonwealth System Of Higher Education

NIDCR EXTRAMURAL RESEARCH PROVIDES RESEARCH FUNDS TO SUPPORT BASIC, TRANSLATIONAL, AND CLINICAL RESEARCH IN DENTAL, ORAL, AND CRANIOFACIAL HEALTH AND DISEASE THROUGH GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS THAT SUPPORT SCIENTISTS WORKING IN INSTITUTIONS THROUGHOUT THE UNITED STATES AND INTERNATIONALLY. EXTRAMURAL PROGRAMS PLAN, DEVELOP, AND MANAGE SCIENTIFIC PRIORITIES THROUGH PORTFOLIO ANALYSES AND CONSULTATION WITH STAKEHOLDERS, ENCOURAGING THE MOST PROMISING DISCOVERIES AND EMERGING TECHNOLOGIES FOR RAPID TRANSLATION TO CLINICAL APPLICATIONS. THE INTEGRATIVE BIOLOGY AND INFECTIOUS DISEASES PROGRAMS SUPPORTS BASIC AND TRANSLATIONAL RESEARCH PROGRAMS ON ORAL MICROBIOLOGY, SALIVARY BIOLOGY AND IMMUNOLOGY, ORAL AND SALIVARY GLAND CANCERS, NEUROSCIENCE OF OROFACIAL PAIN AND TEMPOROMANDIBULAR DISORDERS, MINERALIZED TISSUE PHYSIOLOGY, DENTAL BIOMATERIALS, AND TISSUE ENGINEERING AND REGENERATIVE MEDICINE. THE BRANCH AIMS TO ACCELERATE PROGRESS IN BASIC AND TRANSLATIONAL RESEARCH IN THESE AREAS, AND FURTHER STIMULATE THE DISCOVERY PIPELINE BASED ON CLINICAL NEEDS. THE TRANSLATIONAL GENOMICS RESEARCH PROGRAMS SUPPORTS BASIC AND TRANSLATIONAL RESEARCH IN GENETICS, GENOMICS, DEVELOPMENTAL BIOLOGY, AND DATA SCIENCE TOWARD THE GOAL OF IMPROVING DENTAL, ORAL, AND CRANIOFACIAL HEALTH. THE FOCUS IS ON DECIPHERING THE GENETIC, MOLECULAR, AND CELLULAR MECHANISMS UNDERLYING DENTAL, ORAL, AND CRANIOFACIAL DEVELOPMENT AND ANOMALIES. THE BEHAVIORAL AND SOCIAL SCIENCES RESEARCH PROGRAMS SUPPORTS BASIC AND APPLIED RESEARCH TO PROMOTE ORAL HEALTH, TO PREVENT ORAL DISEASES AND RELATED DISABILITIES, AND TO IMPROVE MANAGEMENT OF CRANIOFACIAL CONDITIONS, DISORDERS, AND INJURY. THE PROGRAM PRIORITIZES MECHANISTIC RESEARCH THAT CONTRIBUTES TO A CUMULATIVE SCIENCE OF BEHAVIOR CHANGE, TO MAXIMIZE THE RIGOR, RELEVANCE, AND DISSEMINATION OF EFFICACIOUS BEHAVIOR CHANGE INTERVENTIONS. THE CLINICAL RESEARCH PROGRAMS SUPPORTS PATIENT-ORIENTED, POPULATION, AND COMMUNITY BASED RESEARCH AIMED AT IMPROVING THE DENTAL, ORAL, AND CRANIOFACIAL HEALTH OF THE NATION. THE CENTER FOCUSES ON A VARIETY OF DISEASES AND CONDITIONS THROUGH CLINICAL TRIALS, EPIDEMIOLOGIC STUDIES, PRACTICE-BASED RESEARCH, THE HIV/AIDS AND ORAL HEALTH PROGRAM, AND STUDIES OF ORAL HEALTH DISPARITIES AND INEQUITIES IN ALL AREAS OF NIDCR PROGRAMMATIC INTEREST. THE PROGRAM ENCOURAGES INVESTIGATIONS THAT HAVE THE POTENTIAL TO TRANSLATE FINDINGS INTO EVIDENCE-BASED CLINICAL APPLICATIONS. THE RESEARCH TRAINING AND CAREER DEVELOPMENT EXTRAMURAL PROGRAMS SPAN THE CAREER STAGES OF SCIENTISTS, SUPPORTING RESEARCH TRAINING AND CAREER DEVELOPMENT FOR PHD AND DUAL DEGREE DDS/DMD-PHD STUDENTS, POSTDOCTORAL SCHOLARS, AND EARLY CAREER, MIDCAREER, AND ESTABLISHED INVESTIGATORS. THE PROGRAMS MANAGE SUPPORT FOR FELLOWSHIPS, RESEARCH TRAINING GRANTS, CAREER DEVELOPMENT AND CAREER TRANSITION AWARDS, NIH LOAN REPAYMENT AWARDS, AND DIVERSITY SUPPLEMENTS TO SUPPORT RESEARCH EXPERIENCES FOR HIGH SCHOOL STUDENTS THROUGH INVESTIGATORS. NIDCR PARTICIPATES IN THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS. THE SBIR PROGRAM IS INTENDED TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.THE STTR PROGRAM IS INTENDED TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. EXTRAMURAL PROGRAMS ARE ACCOUNTABLE FOR THE EFFICIENT AND EFFECTIVE USE OF TAXPAYER FUNDS TO SUPPORT RESEARCH ON DENTAL, ORAL, AND CRANIOFACIAL DISEASES AND DISORDERS AND IMPROVING THE ORAL HEALTH OF ALL AMERICANS. EXTRAMURAL PROGRAMS SUPPORT RESEARCH AND RESEARCH TRAINING TO ESTABLISH THE FOUNDATION FOR SCIENTIFIC DISCOVERIES THAT INCLUDE TRANSPARENT AND RIGOROUS PLANNING, PRIORITY SETTING, CONTINUOUS AND CONSISTENT REVIEWS OF PROGRESS, AND FOCUS ON THE DEVELOPMENT OF A DIVERSE, HIGHLY SKILLED, AND NIMBLE WORKFORCE THAT CAN RAPIDLY RESPOND TO SCIENTIFIC BREAKTHROUGHS AND PUBLIC HEALTH CHALLENGES. EXTRAMURAL PROGRAMS ARE ACCOUNTABLE FOR THE EFFICIENT AND EFFECTIVE USE OF TAXPAYER FUNDS TO SUPPORT RESEARCH ON DENTAL, ORAL, AND CRANIOFACIAL DISEASES AND EMPLOY EVALUATION DOMAINS, FROM NEEDS ASSESSMENT AND STRATEGIC PLANNING TO IMPLEMENTATION AND PROCESS EVALUATION, PERFORMANCE MEASUREMENT, AND OUTCOMES AND IMPACT ANALYSIS TO EVALUATE STRATEGIC OBJECTIVES

93.310 - Trans-NIH Research Support

National Institute of Dental and Craniofacial Research (NIDCR) [HHS - NIH]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Pennsylvania United States

State-Wide

TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (U54 Clinical Trial Optional) (RFA-DE-25-003)

Amendment Since initial award the total obligations have increased 769% from $400,000 to $3,476,015.