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Biostatistics Services

The BBSR biostatisticians collaborate on developing protocols for clinical trials and research proposals for laboratory-based investigations and epidemiologic studies; perform statistical analyses; interpret study results; and co-author presentations and publications. In addition to developing investigator-initiated clinical trials and new research studies, BBSR biostatisticians serve as standing voting members on the Medical Protocol Review and Monitoring Committee (MPRMC), Population Sciences Protocol Review and Monitoring Committee (PSPRMC), and the Data and Safety Monitoring Committee (DSMC). BBSR biostatisticians routinely participate in various Cancer Center forums, such as meetings of the research programs and the Site Disease Groups, and often assist Clinical Research Services (CRS) and the Informatics Applications Management group in the implementation of various projects.

Services

  • Design of clinical and population studies and laboratory experiments
    • Study design and sample size determination/justification
    • Statistical analysis plan for interim and final results
    • Early stopping guidelines for data and safety monitoring
  • Write-up of statistical considerations for grants and protocols
  • Data analysis and interpretation of findings throughout the project
    • Write-up of statistical methods and results for manuscripts, abstracts, presentations, and reports to oversight committees and funding agencies
    • Consultation for database design and data management
    • Assistance with protocol amendments

Technologies

  • Statistical software (commercial): SAS, SPSS, PASS (Power Analysis and Sample Size for Windows), NCSS (Number Cruncher Statistical System), GESS (Gene Expression Statistical System), MS Excel developed modules: BAYES-R, BAYES- S, BERT and SET.
  • Database software: MS Access and REDCap (http://project-redcap.org/).
  • Public domain software: R, SEER*Stat, EWOC (Bayesian dose escalation / de-escalation), PH1ATD (analysis of Phase I trials with accelerated titration designs), OTSD (optimal two-stage designs for Phase II clinical trials), STPLAN (study planning calculations), R code for Bayesian phase II adaptive randomization.

Guidelines for Creation and Documentation of a Data Set

To request support from the BBSR, complete the Investigator Request for Statistical and Bioinformatics Request Form and submit by clicking the “Submit” button on the form or email the form to bbsr@med.miami.edu.