Clinical Translation Core

Project Summary The overall goal of the Clinical Translational Core (CTC) is to efficiently and effectively move basic and applied intellectual and developmental disability research (IDDR) findings into human clinical studies and ultimately clinical practice. The CTC is designed to serve as a “one-stop-

shop” for IDD investigators, providing assistance and services either directly or in collaboration with other institutional resources (especially the Clinical and Translational Science Award (CTSA) program) at each stage of the clinical and translational research (CTR) spectrum at CNH, GW, GU and HU. This includes deep phenotyping, recruitment, performance, analysis,

implementation, commercialization and dissemination. The proposed CTC will be coordinated by an administrative structure that is cost effective and provides specific infrastructure supports for DC-IDDR investigators and their teams. The direct functions of the CTC will include: 1) data mining of large real-world evidence data sources (informatics); 2) patient recruitment and study

performance across multiple venues; 3) consultative support in biostatistics/informatics for planning, designing, and analyzing IDDR studies; 4) connection and collaboration with other IDDRC cores for deep phenotyping/genotyping and bio banking, and 5) training and dissemination through a web based investigator toolkit. The specific aims are: 1) To build a

phenomics framework with a digital platform that integrates clinical and 'omics' data and a companion biorepository; 2) To employ a multi-dimensional strategy to enhance participant recruitment and study implementation/performance; 3) To provide IDDR-relevant study design, biostatistical and informatics support; and 4)To develop an IDDR investigator toolkit.