Data management and biostatistics

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The focus of the Data Management & Biostatistics Core is the acquisition of data, data management, review and analysis all on a web-accessible database for the Microbicide Development Program (MDP). The data management aims are to ensure equal access to relevant forms, databases (trial CRFs), regulatory documents, adverse event (AE) reports and iterative data/results for all program participants, including NIH Project Officers and Scientific Advisory Panel (SAP) members. Of equal importance is for the Program's team members to be able to review their own data often acquired elsewhere), which may be located at different institutions, as well as to participate in teleconferences vhere review of other Projects' results are discussed, eliminating need for multiple and unwieldy email attachments. This approach has great strengths and is pivotal to the efficiency and success of this broadly based program. Once data is reviewed and finalized, biostatistical analysis can proceed in a coordinated fashion with all associated biostatisticians working from the same locked datasets. An additional advantage of this Core is the Co-Directorship of Dr. William Cumberland, Director of the UCLA CFAR Biostatistics Core and Chair of the Biostatistics Department at UCLA. This oversight of statistical and analysis plans in all projects is coordinated to ensure cohesiveness of approach, integration of optimized methods, oversight protection and the summary capacity to assist in overall implications for one project based on f'mdings in another project. We want to ensure that no reasonable microbicide candidate is eliminated from development (Project 4), due to observed mucosal inflammation that may, in fact, be a consequence of trauma related to coitus (Project 2) or prepared in an unacceptable formulation (Project 3). As all these variables can not be evaluated in a single trial, interpretative projections based on common acquisition techniques, similar populations and identical units, will be one of the strengths of this application, making the sum greater than the parts. The Core will facilitate interaction between the statistical personnel and the investigators of the different projects. Key functions will be to encourage collaborative research among the statistical personnel to solve biostatistical problems that arise during the studies. The Core Director & Co-Director will be represented on all teleconferences involving safety and data review as well as in preparation of DSMB reports with the intent that any problems encountered during this novel collaborative research will lead to new statistics methods and publications answer study questions.