Statistics & Data Management Center (SDMC)
The Statistics and Data Management Center (SDMC) at Rho, Inc. performs all of the statistical and data management functions for the Comprehensive Sickle Cell Centers (CSCC), a group comprised of 10 sickle cell research centers across the country and funded by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). In addition, the SDMC acts as a coordinating center for the various multi-center and single center trials.
- Operational Support activities include:
- Facilitating communication between study sites, study collaborators, and the NHLBI
- Supporting the conduct, logistics, and compliance of studies
- Overseeing the collection and maintenance of study documentation, including the maintenance of a project website
- Developing study documents, such as the protocol and Manual of Operations
- Preparing reports for the NHLBI, the Protocol Review Committee (PRC), and the Data & Safety Monitoring Board (DSMB)
- Statistical Analysis activities include:
- Participating as collaborative scientists in all the study's stages, from concept development to study design to manuscript development
- Providing routine analyses of study progress
- Conducting interim analyses in support of the DSMB's activities
- Conducting final analyses and preparing final study reports
- Data Management activities include:
- Developing Case Report Forms (CRFs) for the accurate and efficient collection of study data
- Developing, maintaining, and validating study databases, including the Electronic Data Capture (EDC) system for the various studies.
- Regulatory Support activities include:
- Ensuring that all regulatory documentation is properly collected, reviewed, and maintained
- Assisting in the development and submission of Investigational New Drug applications and other FDA reports and applications
- Monitoring sites to ensure compliance with the protocol and with Good Clinical Practice (GCP), NIH, and FDA requirements
- Facilitating safety communication between sites and the NIH
Sickle Cell Disease
Sickle Cell Disease is a group of related genetic disorders that affect red blood cells. Sickle Cell Anemia (SCA) is the most prevalent form, but other forms such as hemoglobin SC disease and sickle beta-thalassemia are also common. All forms of sickle cell disease are marked by anemia (a low red blood cell count) and by crescent-shaped red blood cells. Normal hemoglobin is called hemoglobin A, but people with sickle cell disease have only hemoglobin S, which turns normal, round red blood cells into abnormally curved (sickle) shapes.
The Comprehensive Sickle Cell Centers (CSCC) Program was established by the Sickle Cell Disease Control Act of 1972. In response to this Presidential initiative and Congressional mandate, the NHLBI established a National Sickle Cell Disease Program to include comprehensive research centers selected by open competition every 5 years. For the first time, in the 2003-2008 funding cycle, a mechanism for Inter-Center clinical trials was included to enable the 10 funded CSCCs to carry out multi-center translational research focused on the development of curative therapies and the improvement of medical treatment of sickle cell disease. This Comprehensive Sickle Cell Centers Clinical Trials Consortium (CSCC-CTC) establishes research priorities, and designs and conducts large multi-center investigations to address these broad goals.
Current Multi-Center Projects Supported by the SDMC:
- Arginine Supplementation in Sickle Cell Anemia: Physiological and Prophylactic Effects
- Comprehensive Sickle Cell Centers Collaborative Data Project
- Neuropsychological Dysfunction and Neuroimaging Abnormalities in Neurologically Intact Adult Patients With Sickle Cell Disease (SCD)
- Epidemiology of Priapism
- Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
- Randomized Trial of Oral Dexamethasone for Acute Chest Syndrome
For more information about these studies, click here.
SDMC Personnel
Susi Lieff, Ph.D.
Principal Investigator
Phone: 919-408-8000 ext 467
Fax: 919-287-0126
Email:
slieff@rhoworld.com
Ronald Helms, Ph.D.
Co-Principal Investigator
Phone: 919-408-8000 ext 222
Fax: 919-408-0999
Email:
ron_helms@rhoworld.com
Karen Kesler, Ph.D.
Senior Biostatistician, Co-Principal Investigator
Phone: 919-408-8000 ext 244
Fax: 919-287-0126
Email:
kkesler@rhoworld.com
Marsha McMurray
Project Director
Phone: 919-408-8000 ext 279
Fax: 919-287-0126
Email:
mmcmurra@rhoworld.com
Cathie Snyder
Senior Study Coordinator
Phone: 919-408-8000 ext 291
Fax: 919-287-0126
Email:
csnyder@rhoworld.com
Melanie Chelednik
Study Coordinator
Phone: 919-408-8000 ext 356
Fax: 919-287-0126
Email:
mcheledn@rhoworld.com
Petra LeBeau
Statistician
Phone: 919-408-8000 ext 227
Fax: 919-287-0126
Email:
plebeau@rhoworld.com
Barry Eggleston
Statistician
Phone: 919-408-8000 ext 278
Fax: 919-287-0126
Email:
begglest@rhoworld.com
Allison Overington
Research Associate
Phone: 919-408-8000 ext 581
Fax: 919-287-0126
Email:
aoverington@rhoworld.com
Emily Kunka
Research Associate
Phone: 919-408-8000 ext 585
Fax: 919-287-0126
Email:
ekunka@rhoworld.com
Jason Davis
Research Associate
Phone: 919-408-8000 ext 344
Fax: 919-287-0126
Email:
jmdavis@rhoworld.com
Mailing Address:
Rho Federal Systems Division
6330 Quadrangle Drive
Suite 500
Chapel Hill, NC 27517