Project: Research project

Project Details


This application proposes the creation of a Data Coordinating Center for a
multicenter clinical trial entitled "Growth Failure in Children with Renal
Diseases". The clinical trial will evaluate, in a double-blind design,
linear growth of children with chronic renal failure under treatment with
either 1,25-dihydroxyvitamin-D3 or dihydrotachysterol and will assess
efficacy and safety of these two treatments. A sample of 120-160 children
aged 2-11 years will be followed up to 45 months. Specific objectives of
the Data Coordinating Center include: 1) working closely with the
Principal Investigator of the clinical trial in the administration and
control of the study; 2) ensuring accuracy, reliability, validity,
completeness and security of all data; 3) providing expert statistical
analysis and interpretation of results. The Data Coordinating Center will
be responsible for all document and data forms preparation, study personnel
training and orientation, study design and double-binding protocol, data
management and quality control as well as interim and final statistical
analysis and dissemination of results. The Principal Investigator of this
project is Walter H. Carter, Jr., Ph.D., Professor of Biostatistics,
Department of Biostatistics, Medical College of Virginia, Richmond,
Virginia. The proposed Data Coordinating Center will work in concert with
a four-member Executive Committee (including the Principal Investigator and
Co-Investigators of the clinical trial) and an Advisory Committee composed
of pediatric nephrologists, a biostatistician and a clinical nutritionist.
This project has the endorsement of the Chairman of the Department of
Biostatistics and the Dean of the School of Basic Sciences, Medical College
of Virginia.
Effective start/end date12/31/8912/31/92