Core B: Clinical Translational Core

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PROJECT SUMMARY: CLINICAL TRANSLATIONAL CORE (CTC) The Clinical Translational Core (CTC) of the Hawk-IDDRC seeks to address the challenges faced by those living with IDD at all life stages by providing investigators the resources to transition discoveries from the laboratory into clinical practice, and enable an understanding of the biology underlying clinical observations, in order to advance translational research. The CTC differentiates itself by providing infrastructure for recruiting rural populations as well as participants at key transition points across the lifespan, including: the perinatal period, puberty and adolescence, adulthood at varying levels of independence, and later adulthood as professional caregivers assume a primary role. These transition points represent critical periods that influence the long-term wellbeing of those living with IDD, yet our understanding of each is limited. Importantly, rural populations 1) have decreased access to appropriate care, 2) have different potential IDD exposures that are not well studied, and 3) lack research infrastructure. The Hawk-IDDRC CTC is poised to fill these needs and will thus provide access to unique clinical data and biosamples from this understudied population by carrying out the following aims: 1) Facilitate and accelerate the recruitment and clinical evaluation of IDD-affected patients at all stages of life and from diverse areas to connect them and their families with clinical studies and resources; 2) Provide IDD researchers with biobanking and bioinformatics services; 3) Facilitate and support the design, development, and testing of novel IDD therapies by providing a successful architecture for clinical trials and drug manufacturing services to IDD researchers. The expertise and resources of the CTC Co- Directors (Mark Santillan and Alexander Bassuk) covers a broad spectrum of capabilities, ranging from prenatal risk assessment, to human subject recruitment, and banking of clinical data and biosamples. Specific assets of the University of Iowa (UI) that cover the lifespan include CoLab (Global Pregnancy Collaboration), an international collaboration of 40 sites focused on pregnancy outcome research, sharing clinical data and biosamples; a clinical recruitment center for SPARK, a nationwide genetic study of autism; UI-led statewide networks of collaborating clinics, schools, and providers in rural and urban areas; and the Intellectual Disability- Mental Illness (ID-MI) clinic, one of only a handful of inpatient units in the country that focuses on patients with intellectual disability and a co-occurring mental illness. The CTC will serve as a central focal point for these resources, streamlining access for investigators, and enabling its support of 31 federally funded projects totaling $12.6 million per year. The access to a unified, harmonized source of clinical data, biosamples, and clinical cohorts allows the CTC to work with all Cores to perform retrospective and prospective IDD studies. The resources of the CTC will support the mission of the Hawk-IDDRC to provide an organizational structure that integrates basic and clinical research across the lifespan—from conception to adulthood—focused on the prevention, diagnosis, treatment and amelioration of IDDs, and tailored to a rural, underserved population.