General Clinical Research Center

EXCEED THE SPACE PROVIDED. We propose funding of a GCRC at Children's National Medical Center (CNMC), with a satellite program at Georgetown University Medical Center (GUMC). The goal of our integrated GCRC program is to provide the infrastructure for patient-oriented research at our two institutions, leading to improved healthcare of children and adults through innovative studies of mechanism and treatment of disease. The Pediatric GCRC at CNMC was initially funded as a satellite program of the GUMC GCRC in September 2000. During its first three years of operation it has increased the number of protocols from 25 to 142, of which 83 are included in this application. The number of GCRC investigators has increased from 14 to 43 during the same period. The GUMC GCRC has also grown from 41 protocols in 1999 to 215 of which 82 are included here, and the number of GCRC investigators has increased from 49 to 111 during the same period. NIH grant support for research has increased at both institutions during the same period, at GUMC from $65 to $73 million, and at CNMC from $8 million to $23 million, including funding of two major NCRR initiatives that extensively utilize the GCRC resources: a K12 Clinical Research Scholars Award and a Rare Diseases Clinical Research Center. This proposal seeks support for a total of 165 protocols covedng a broad spectrum of pediatric and adult diseases ranging from rare genetic disorders in national and international populations to common issues in public health of the Washington DC metropolitan population. There are significant collaborations among clinician-investigators in the clinical departments, between clinical and basic science departments, and between investigators at both institutions. Of the protocols proposed for GCRC support, 122 protocols are funded by NIH and 32 have other peer-reviewed extramural funding. The seven presented projects highlight scientific strengths in patient-oriented investigations including genetics and metabolism, clinical pharmacology, neuroscience, cancer and community health research. We propose the continuation of our integrated Biostatistics/Informatics and Bionutrition Research support, Genetics, Bioanalytical and Neurobehavioral &Psychosocial Evaluation cores, and a new Neuroimaging core. An efficient and integrated administrative structure between the two institutions has been developed, including a combined GCRC Advisory Committee and the sharing of research protocols that have both pediatric and adult components. Strong combined programs of education and training in patient-oriented research include the Clinical Research Scholars Award program and programs in human subject protection and ethics. This application therefore combines the strengths of both institutions to advance patient-oriented research and training in Washington DC.