Sep 30 2009
The Burzynski Research Institute, Inc. (BRI) today announced that it has signed a Research Agreement with the UAB Division of Preventive Medicine, Biostatistics and Bioinformatics Shared Facility (BBSF) that will provide biostatistical and data management support for BRI’s ongoing Phase II and Phase III protocol studies of Antineoplaston (ANP) treatment for gliomas.
The BBSF has the experience and capacity to assist BRI with developing statistical analysis plans; database design; data receipt, management, and long term storage; implementation of quality assurance plans; and the generation of data quality, and study outcome data reports for scientific presentations, publications, and reports. The BBSF is continuing to develop new statistical methodologies, new information technology and approaches to databases, new approaches to quality assurance programs, more efficient procedures for incorporating the results of statistical analyses into reports, presentations and publications, and more efficient and cost effective systems for long term data storage, backup, and retrieval.
“We are very enthusiastic about our association with BBFF. While our Research Agreement has only recently been formalized, BBFF has already assisted BRI in the development of an FDA-approved Phase III protocol study of Antineoplaston therapy for glioma and in the development of a novel Phase II protocol study of Antineoplaston therapy for glioma, which is currently being submitted for FDA approval. Both studies involve multiple international sites and BBFF’s expertise in international data management will prove invaluable.”