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Biostatistics

Biostatistics. GCRC Biostatistics Core. A team of biostatisticians assists GCRC investigators with: • Design of Clinical Studies • Research Database Development • Data and Safety Monitoring Board (DSMB) • Analysis and Reporting of Study Results

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Biostatistics

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  1. Biostatistics

  2. GCRC Biostatistics Core • A team of biostatisticians assists GCRC investigators with: • Design of Clinical Studies • Research Database Development • Data and Safety Monitoring Board (DSMB) • Analysis and Reporting of Study Results • Lectures on Clinical Biostatistics

  3. Design of Clinical Studies • Statistical formulation of primary and secondary endpoints and exploratory research questions. • Identifying and eliminating source of variation • Provide sample size calculation. A user-friendly Web-based interactive sample size calculation program by David Schoenfeld, Ph.D. is also available. http://www.hedwig.mgh.harvard.edu/sample_size/size.html • Development of data analysis plan • Provide randomization scheme via pharmacy sheets, envelopes, etc.

  4. Research Database Development • Work with GCRC systems manager or independently to aid in developing study database structure (Excel, Access, etc). • Conversion of the databases into statistical analysis files (such as SAS files).

  5. Data and Safety Monitoring Board (DSMB) • GCRC biostatisticians can serve as a DSMB member of a study. • GCRC biostatisticians can provide the DSMB report to the DSMB as per board’s request.

  6. Analysis and Reporting of Study Results • Using the protocol’s data analysis plan, biostatisticians analyze data interactively with investigators or independently. • Work with investigators to interpret results and write statistical methods section. • Proofread manuscripts for accuracy of reported numbers, clarity of presentation and valid interpretation of the results.

  7. Commonly Applied Methods • Methods of classical parametric and non-parametric inference: ANOVA, linear and logistic regressions; correlations and associations; longitudinal and clustered data. • Mixed effects models: generalized estimating equations; repeated measure ANOVA; survival analysis; non-linear models, etc. • Available software: SAS, Splus, Matlab, Mathematica, DBMSCopy, WinBugs, Pulsa pulse detection software, Graphad prism.

  8. Lectures on Clinical Biostatistics • Format: Five-week course of one-hour lecture followed by 30-minute discussions in each weekly session (every January) for fellow or junior faculty level clinical investigators Text:Basic and Clinical Biostatistics by Beth Dawson-Saunders and Robert G. Trapp Topics: Study Design, Summarizing Data, Estimating and Comparing Means and Proportions, Power and Sample Size, Correlation and Regression for Multiple Variables

  9. Contact Us! • Location: MGH Biostatistics Center, 50 Staniford Street 5th Floor http://hedwig.mgh.harvard.edu/biostatistics • GCRC Statisticians: Primary Contact Person: Hang Lee, Ph.D. hlee5@partners.org (617) 726-4293 David Schoenfeld, Ph.D. (Director and Professor, GAC Member) Mark Vangel, Ph.D. Douglas Hayden, MA 617 – 726 – 4293.

  10. Go Back to GCRC Orientation

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