The Statistical and 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 Stroke With Transfusions Changing to Hydroxyurea (SWiTCH) study.
- 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
Clinical Coordinating Center
The clinical coordinating center for SWiTCH is: St. Jude Children's Research Hospital
SWiTCH Overview
The primary goal of the Phase III SWiTCH trial is to compare 30 months of alternative therapy (hydroxyurea and phlebotomy) with standard therapy (transfusions and chelation) for the prevention of secondary stroke and reduction of transfusional iron overload in pediatric subjects with sickle cell anemia and previous stroke. In order for the alternative treatment regimen (hydroxyurea and phlebotomy) to be declared better than the standard treatment regimen (transfusions and chelation), the hydroxyurea-treated group must have both a recurrent stroke rate similar to that with transfusion prophylaxis and a greater reduction in liver iron stores.
