The Biostatistics Core Component (BCC) serves as the centralized resource to the investigators of the Program Project Grant on """"""""Hematopoietic Cell Transplantation for Hematologic Malignancy,"""""""" providing the management services and biostatistical consultation to all projects.
The specific aims of the BCC are: 1. To assist in the planning of the projects of the grant, both basic science and clinical studies, including study design, sample size projections, randomization, analytic plan and statistical methodology. 2. To provide database management, computerization of data, and integration with other existing sources of electronic data. 3. To provide data management, computerization of data, and integration with other existing sources of electronic data. 4. To perform quality control assurance of the data collection and computerization, including routine audits of in-house protocol data. 5. To perform statistical programming and analysis of study results. 6. To collaborate in the writing of society abstracts and peer-review publications reporting on these data. The BCC staff will consist of the Core Director, Senior Data Analyst, Biostatistician/Programmer Analyst, Clinical Trials Administrator, and Clinical Research Associates. Additional support is provided to the Program Project Grant by members of the Biostatistician Department, including the Quality Control Coordinator, Data Entry Clerks, Systems Administrator, and Database Coordinator, at no cost to the grant. Mechanisms are in place for providing randomization, study design, protocol review, protocol and data management, audits of in-house protocols, data requests and statistical analyses. Analyses are performed using the SAS and S-PLUS software packages, as well as other specialty software for statistical applications. A clinical trials software program has been developed in-house to manage research data on all bone marrow transplant (BMT) populations, and currently contains data on over 3,000 BMT recipients. The recently created Department of Biomedical Informatics, joined with the Department of Biostatistics through the Division of Information Sciences chaired by Dr. Niland, provides support for systems development and information integration to optimize research computing. The BCC is closely integrated with the Long Term Follow-up Core, on which Dr. Niland is a co-investigator. Statistical analyses performed during the current funding period have led to over 30 collaborative publications with members of the BCC as co- authors. The BCC has had input into all of the in-house study designs for the specific aims of the current proposal, and will continue to provide critical support for all six projects of the grant during its conduct.
Showing the most recent 10 out of 364 publications
