The overall objective of the Clinical Translational Core is to provide IDDRC-supported investigators with access to a broad range of supports of critical importance for the effective and efficient conduct of translational research focused on developmental disorders. Core resources are structured to coordinate those services of the core, proper, and to ensure that the core interacts seamlessly with complementary resources available in affiliated programs, including the Kennedy Krieger Institute’s (KKI’s) Clinical Trials Unit (CTU). This aim continues our Center’s commitment to enhancing the conversion of basic science discoveries into effective therapies for children and adults with genetic and acquired developmental disabilities.
This core is structured to complement our CTU, a program focused on the development of treatments targeting developmental disorders, including conducting investigational drug trials at all phases and supporting industry sponsorship of clinical trials. The Clinical Translational Core substantially expands upon CTU capabilities to provide expert resources including consultation on biostatistics and protocol design, pre-review prior to submission of protocols to the institutional review board (IRB) and hands-on advice and help with carrying out investigational protocols by experienced trialists, research coordinators and administrative staff.
To accomplish these goals, the core provides IDDRC investigators with access to infrastructure and expertise focused on translation of basic science advances in the understanding of the pathogenesis of childhood neurodevelopmental disabilities into clinical trials of possible therapies for these disorders. This includes assistance with:
- recruitment of research participants through coordination with clinical programs, coordination of existing databases, development of new recruitment resources, and faculty participation in national registry development;
- the conduct of clinical trials, facilitating access to the resources and expertise available within KKI’s CTU;
- obtaining approvals from the IRB and the IACUC, as required;
- moving ideas and findings along the entire translational continuum and toward implementation in practice;
- accessing consultation and collaboration in the area of biostatistics;
- coordinating with other components of our IDDRC and with affiliated programs throughout Johns Hopkins involved in translational research.