RFA-HD-13-002 requires the inclusion of a Clinical Translational Core within each IDDRC, addressing a combination of activities that includes: (a) recruitment of research participants, (b) subject assessment, phenotyping, or treatment, (c) development of biomarkers, (d) manufacturing services, (e) highthroughput screening, and/or (f) collection of samples from individuals with IDD for biobanking. As described in our Introductory Overview and the following Core descriptions, many of these activities are supported by other Cores and existing resources within the large and multidisciplinary research environment developed within our Institutions over the years. Therefore, the overall objective of the Clinical Translational Core is to complement those resources and coordinate access for IDDRC-supported investigators. This will contribute to our primary goal of enhancing the conversion of basic science discoveries into effective, commercially available disease-altering therapies for children and adults with genetic and acquired intellectual and developmental disabilities. The Core will be structured to complement our Clinical Trials Unit (CTU), a program established three years ago in response to the increasing emphasis on translational research within our IDDRC and the broader research program it supports. The CTU is focused on the development of treatments targeting developmental disorders, including conducting investigational dmg trials at all phases. The Clinical Translational Core will expand 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 clinical trials faculty, research coordinators and administrative staff.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
1U54HD079123-01A1
Application #
8846263
Study Section
Special Emphasis Panel (ZHD1-DSR-H (ID))
Project Start
Project End
Budget Start
2014-09-23
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$177,940
Indirect Cost
$40,039
Name
Hugo W. Moser Research Institute Kennedy Krieger
Department
Type
DUNS #
155342439
City
Baltimore
State
MD
Country
United States
Zip Code
21205
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