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Principal Investigator: Eva Petkova
Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Fiscal Year: 2020
Award: $1,333,195
Funding agency: National Institute of Neurological Disorders and Stroke
The Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will
be the data and biospecimen manager for pain research within the HEAL Partnership. As such, it will host,
manage, standardize, curate, and provide a sharing platform for data and biospecimens for HEAL initiatives,
such as the Acute to Chronic Pain Signature initiative and the BACPAC, in addition to EPPIC-Net studies. The
DCC will develop and maintain a databank for depositing pre-clinical, clinical, neuroimaging, microbiome,
genomics, and other omics biomarker data, will link these data with a repository for biological samples, and will
create a platform for teams to work together to analyze and interpret data. Further, the DCC will provide
leadership in the statistical design and analysis of EPPIC-Net studies, and will deploy advanced systems and
processes for data collection, management, quality assurance, and reporting. The DCC will create, sustain,
and continually advance a robust organization for the rapid design, implementation, and performance of high-
quality rigorous Phase II clinical trials to test promising therapeutics for pain. The proposed DCC brings
together experts from statistics, clinical trials design and simulation, data management, neuroimaging,
bioinformatics, genomics, and radiology, and leverages decades of experience instituting and running large
data sharing consortia and data coordinating centers. Our aims are to further the goals of EPPIC-Net and the
HEAL initiative through: 1) Integration of the DCC within the EPPIC-Net structure and facilitation of the alliance
with HEAL partners; 2) Provision of biostatistical expertise, support, and leadership to EPPIC-Net studies; 3)
Provision of legacy and de novo secure data storage and comprehensive data management for EPPIC-Net
studies; 4) Institution of a pain-related expandable biospecimen repository; and 5) Establishment of the EPPIC-
Net DataExchange and BiospecimenExchange to foster the development of non-addictive treatments for pain.
The DCC will be structured around four cores: 1) an Administrative Core; 2) a Statistical Core; 3) a Data Core;
and 4) a Biospecimen Core. This DCC will work with the EPPIC-Net Clinical Coordinating Center (CCC) and
with the Specialized Clinical Centers (SCC, a hub and its spokes/clinics) to educate clinicians and staff in good
clinical trial practices for reproducibility of research, and to train them in the data management system and
procedures employed in the network. The DCC will provide sites with user-friendly dashboards to monitor their
own performance and will promote collegial and supportive relationships with the sites’ personnel to cultivate
rigorous and enthusiastic engagement in the conduct of the studies. The DCC will use state-of-the-art concepts
and techniques in the acquisition, transfer, storing, management, standardization, linking, and curation of the
clinical and biomarker data to launch and maintain the EPPIC Exchange encompassing the DataExchange,
and the BiospecimenExchange. The EPPIC Exchange represents the final product delivered by the DCC -- a
resource with capability for continual growth, that will be shared by the pain research community.
Terms: <2019 novel coronavirus><2019-nCoV><21+ years old><Active Follow-up><Acute><Admission><Admission activity><Adult><Adult Human><Aggregated Data><Ataxia><Ataxy><Bio-Informatics><Bioinformatics><Biological><Biological Markers><Biological Specimen Banks><Biological Substance Banks><Biometrics><Biometry><Biostatistics><Brain Inflammation><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID19><COVID19 epidemic><COVID19 pandemic><Caring><Cataloging><Catalogs><Cephalalgia><Cephalgia><Cephalodynia><Childhood><Clinic><Clinical><Clinical Data><Clinical Research><Clinical Study><Clinical Trials><Clinical Trials Design><CoV emergence><Collaborations><Collection><Common Data Element><Communities><Complement><Complement Proteins><Coordination Impairment><Coronaviridae><Coronavirus><Cranial Pain><Data><Data Aggregation><Data Banks><Data Bases><Data Collection><Data Coordinating Center><Data Coordination Center><Data Management Resources><Data Management System><Data Sources><Data Storage and Retrieval><Databanks><Databases><Deposit><Deposition><Development><Disease><Disorder><Dizziness><Dysfunction><Dyssynergia><Encephalitis><Enrollment><Ensure><Event><FAIR data><FAIR principles><Findable, Accessible, Interoperable, and Reusable><Fostering><Functional disorder><Future><General Radiology><Generalized Growth><Genomics><Goals><Government><Growth><Gustation><Head Pain><Headache><Healthcare><History><Hospital Admission><Hospitalization><Human Resources><Impairment><Individual><Infection><Institutes><Institution><International><Intervention><Intervention Strategies><Intubation><Investigators><Jobs><Knowledge><Leadership><Life Experience><Link><Location><Lung diseases><Manpower><Maps><Monitor><Muscle Disease><Muscle Disorders><Muscular Diseases><Myopathic Conditions><Myopathic Diseases and Syndromes><Myopathic disease or syndrome><Myopathy><NIH><NINDS><National Institute of Neurological Diseases and Stroke><National Institute of Neurological Disorders and Stroke><National Institutes of Health><Natural History><Neurologic><Neurologic Manifestations><Neurologic Signs and Symptoms><Neurologic Symptoms><Neurological><Neurological Manifestations><Neurological Signs and Symptoms><New York><New York City><O element><O2 element><Occupations><Olfaction><Organism><Oxygen><Pain><Pain Control><Pain Research><Pain Therapy><Pain management><Painful><Parents><Participant><Patient Care><Patient Care Delivery><Patients><Performance><Phase><Phase 2 Clinical Trials><Phase II Clinical Trials><Physiopathology><Predisposition><Preparation><Prevalence><Procedures><Process><Professional Positions><Protocol><Protocols documentation><Publishing><Pulmonary Diseases><Pulmonary Disorder><Radiology><Radiology Specialty><Recommendation><Recording of previous events><Reporting><Reproducibility><Research><Research Personnel><Research Resources><Researchers><Resolution><Resources><Respiratory Disease><Respiratory System Disease><Respiratory System Disorder><Running><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Sampling><Secure><Seizures><Severe acute respiratory syndrome coronavirus 2><Shipping><Site><Smell><Smell Perception><Source><Specialist><Standardization><Structure><Susceptibility><Symptoms><System><Taste><Taste Perception><Techniques><Testing><Therapeutic><Time><Tissue Growth><Training><Travel><Unconscious><Unconscious State><Unconsciousness><United States><United States National Institutes of Health><Visit><Work><Wuhan coronavirus><active followup><adulthood><advanced system><base><bio-markers><biobank><biologic marker><biological specimen repository><biomarker><biorepository><biosample repository><biospecimen repository><cerebral vascular><cerebro-vascular><cerebrovascular><chronic pain><clinical biomarkers><clinical center><clinical data repository><clinical data warehouse><clinical investigation><clinical research site><clinical site><clinically useful biomarkers><co-morbid><co-morbidity><comorbidity><consciousness loss><corona virus><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><coronavirus disease 2019><coronavirus disease 2019 epidemic><coronavirus disease 2019 pandemic><coronavirus emergence><dashboard><data base><data cleaning><data cleansing><data de-identification><data deidentification><data depository><data dictionary><data integration><data management><data repository><data retrieval><data sharing><data standardization><data standards><data storage><data warehouse><de-identified data><deidentified data><demographics><depository><design><designing><developmental><disease of the lung><disorder of the lung><emergent CoV><emergent coronavirus><emerging CoV><emerging coronavirus><enroll><experience><faculty research><follow up><follow-up><followed up><followup><gustatory perception><gustatory processing><gustatory response><head ache><health care><individual patient><internet portal><interventional strategy><living system><lung disorder><microbiome><mortality><muscular disorder><nCoV><neural manifestation><neuro-imaging><neuroimaging><new CoV><new coronavirus><novel CoV><novel coronavirus><odor perception><olfactory perception><on-line portal><online portal><ontogeny><open source><pain treatment><pandemic><pandemic disease><pathophysiology><pediatric><personnel><phase II protocol><pre-clinical><preclinical><quality assurance><radiologic imaging><radiological imaging><repository><sharing platform><simulation><skeletal><specimen bank><specimen repository><statistics><taste processing><taste response><user-friendly><virtual><web portal><web-based portal>