Investigators: Snyder, PJ; Ellenberg, SS
The CRCU collaborated with the Testosterone Trial Steering Committee for four years in the development of this randomized, placebo-controlled, double-blind study of seven coordinated trials. This preliminary period included a feasibility pilot study and a validation study of several standard instruments using the interactive voice response system. The multi-center set of trials include 12 clinical sites geographically distributed across the United States, a central laboratory, investigational drug service, cognitive function reading center, interactive voice response calling center and prostate biopsy reading center, and pharmacogenomic laboratory.
Investigators: Feldman, HI; Landis, JR
The CRIC Scientific and Data Coordinating Center at Penn receives data and provides ongoing support for a number of Ancillary Studies approved by the CRIC Cohort utilizing both data collected about CRIC study participants as well as their biological samples.
Investigators: Dember, LM; Landis, JR
The CRCU serves as the Data Coordinating Center for the Hemodialysis Novel Therapies Consortium (HDNT) - a partnership between four highly-regarded clinical centers, the University of Pennsylvania, and the National Institutes of Diabetes, Digestive, and Kidney Diseases (NIDDK). The HDNT Consortium was established by the (NIDDK) to design and conduct pilot and feasibility studies of novel therapies to reduce morbidity and mortality for patients treated with maintenance hemodialysis.
The Clinical Research Computing Unit (CRCU) in its role as the Data Coordinating Core (DCC) for the MAPP Research Network, provides overall coordination, logistical support, and implementation for all aspects of the study protocol including data collection, data processing, tracking of participant recruitment, tracking of specimens, training, quality assurance, and statistical analysis, through its clinical data management, project management, and software systems development teams.
The University of Pennsylvania, with funding from the Patient-Centered Outcomes Research Institute (PCORI), has designed the Regional vs. General Anesthesia for Promoting Independence after Hip Fracture Surgery (REGAIN) clinical research trial to determine whether one type of standard care anesthesia given to patients undergoing surgery for a hip fracture leads to better outcomes in recovery of walking, overall health and disability, pain, and survival. This trial will enroll more than 2000 patients in over 25 cities in the United States and Canada.
The CRCU functions as a Data Coordinating Center for the Sustained Aeration of Infant Lungs (SAIL) Trial, a multi-national prospective randomized controlled study. SAIL consists of 21 participating Neonatal Intensive Care Units (NICUs) in the USA, Canada, Italy, Germany, Netherlands, Australia, Singapore and South Korea.
The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age. An objective and validated measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are in development but not yet ready for use in a multi-center large clinical study.
Funding: National Eye Institue
Investigator: Maguire, MG
The DREAM study is a set of two multicenter randomized placebo controlled clinical trials designed to evaluate the effectiveness and safety of omega 3 fatty acid supplementation for treatment of patients with mild to moderate dry eye disease (DED).
The Clinical Research Computing Unit (CRCU) was contracted by Dr. Carl June in 2012 to provide a 21 CFR Part 11 compliant Data Integration System in support of the Engineered T Cells for Cancer Project. The goals of this project was to develop an integrated, personalized medicine data system incorporating a comprehensive set of clinical, manufacturing and biomarker data from an extensive array of data sources.
Investigators: Hoxie, JA; Ellenberg, SS
The Penn Center for AIDS Research (Penn-CFAR) is one of 18 NIH-funded CFARs, and includes HIV and AIDS investigators at the University of Pennsylvania, the Children's Hospital of Philadelphia (CHOP), and the Wistar Institute.