The role of the Biostatistics Core Component (BBC) of the program project grant is to serve as a centralized resource to the investigators of the program project for Bone Marrow Transplantation for Hematologic Malignancies, to provide data management services and biostatistical consultation as needed.
The specific aims of the BBC are: 1. To assist in the planning of the projects of the grant, including study design, sample size projections, randomization, analytic plan and statistical methodology. 2. To provide protocol management and data collection for the clinical studies of the program project. 3. To provide database management and computerization of data for both the basic science and clinical studies. 4. To perform quality control assurance of the data collection and computerization, including routine audits of in-house protocol data. 5. To perform statistical analysis of study results, and collaborate in the writing of manuscripts reporting these data. The BBC staff will consist of the Principal Investigator, Ph.D. Biostatistician, MS. Biostatistician, Database Coordinator, and 3.4 Data Managers. Mechanisms are currently in place for providing randomization, study design, protocol review, protocol and data management, audits of in- house protocols, data requests and statistical analyses. Analyses will be performed using the SAS and BMDT software packages, as well as other software for specialized applications. Computer resources are available to the BBC via a local area network of personal computers within the Department of Biostatistics. In addition links to the fiber optic cabling at COH allow inter-connection with any other network or mainframe on campus. A clinical trials software program (the Biostatistics Information Tracking System BITS) has been developed in-house, and currently contains over 1800 records of data on bone marrow transplant patients. The BCC has developed customized data collection instruments and databases specific to the following: autologous BMT lymphoma patients, autologous BMT leukemia patients, related/unrelated donor transplants, radioimmunotherapy patients, induction therapy for ANLL patients, quality of life results and follow-up information. These data are linked with the accession/randomization information residing in BITS, and automated flowsheets have been programmed by downloading Laboratory data from the SunQuest lab system. Statistical analyses performed during the current funding period have let to numerous collaborative publications. The BCC has had input into all of the designs for the specific aims of the current proposal.
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