CORE B ? CLINICAL TRANSLATIONAL CORE Lisa Guay-Woodford, MD Core Director Director, CTSI-CN Children?s National Health System Avital Cnaan, PhD Director, Biostatistics Children?s National Health System Marni Jacobs, ScD Faculty Biostatistician Division of Biostatistics and Study Methodology Children?s National Health System Adeline Vanderver, MD Core Co-Director Director, Myelin Disorders Clinic Children?s National Health System Robert J. McCarter, ScD Associate Director, Biostatistics Children?s National Health System Dongkyu Kim, PhD Informatician and i2b2/SHRINE Architect Division of Biostatistics and Study Methodology Children?s National Health System Abstract The Clinical Translational Core (CTC) is a new function for the DC-IDDRC, designed to serve as a ?one-stop- shop? for IDD investigators, providing assistance at each stage of the clinical and translational research (CTR) spectrum. Its overall goal is to efficiently and effectively move basic and applied research findings into human clinical studies and ultimately into clinical practice through the implementation and dissemination of therapeutic drugs, biologics, devices and software. To optimally serve IDDRC investigators, the CTC will partner with and leverage the core resources of the two Washington DC-based CTSA-funded programs that involve partnerships between 1) Children?s National Health System (CNHS) and The George Washington University (GWU) (the Clinical and Translational Science Institute at Children?s National; CTSI-CN) and 2) Georgetown University and Howard University (the Georgetown-Howard Universities Center for Clinical and Translational Science; GHUCCTS). It will also work on coordinating access to core services within the Mid-Atlantic IDDRC consortium (MAC) that includes the Children?s Hospital of Philadelphia (CHOP), the Kennedy Krieger Institute (KKI) and CNHS. These partnerships will increase cost-efficiency in resource access, minimize wasteful duplication, and maximize the impact of the CTC for our investigators.
Three Aims are proposed to fulfill the mission of the CTC: 1) Integrate the local clinical and translational research functions for investigator-initiated IDD studies. The CTC will establish a flexible and streamlined administrative structure that minimizes barriers and provides specific infrastructure supports for DC-IDDRC investigators and their teams to assure the conduct of efficient, effective and high quality CTR; 2) Integrate regional IDDR resources through the Mid-Atlantic IDDRC consortium (MAC). The CTC will broaden DC-IDDRC investigator knowledge about and access to essential services and expertise available at other institutions in the MAC to provide investigators with access to the full range of CTR methodologies and expertise available; and 3) Integrate resources from the NIH intramural program/clinical research center and industry partners to facilitate collaborative partnerships that include the availability of high throughput screening of cells, tissues, and experimental models for preclinical biomarker and therapeutic efficacy studies. The CTC will also assist DC- IDDRC investigators with issues related to technology transfer, commercialization, and intellectual property protection. Therefore, the CTC will serve as an integrator for the DC-IDDRC, interacting with investigators from project conception to completion and dissemination of results, as well as providing an effective interface for DC-IDDRC investigators with the DC-based CTSA-funded programs, our MAC collaborators, and NIH and industry partners. These functions will promote efficient, impactful and compliant CTR that facilitates the development, implementation, and dissemination of new diagnostic and therapeutic advances for the care of individuals with IDD.
CLINICAL TRANSLATIONAL CORE (CTC) The DC-IDDRC Clinical Translational Core (CTC) will serve as a ?one-stop-shop? for IDD investigators, providing assistance at each stage of the clinical and translational research spectrum. The CTC is designed to efficiently and effectively move basic and applied research findings into human clinical studies and ultimately, into clinical practice. The overall goal of the CTC is to assist with the development, implementation, and dissemination of new diagnostic tools as well as therapeutic drugs, biologics, devices and software that advance the care of individuals with IDD.
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