Practical Biostatistics

Mendel Suchmacher, MD, MSc, graduated in Pharmaceutical Medicine at Federal University of the State of São Paulo, is Board Certified in Internal Medicine and Hematology-Hemotherapy and member of the American College of Physicians. He holds teaching and research positions at prestigious Brazilian institutions: Professor of Clinical Immunology at Carlos Chagas Institute of Medical Graduation; Professor & Chairman of Microbiology and Immunology, and Research Fellow at Teresopolis University Medical School - UNIFESO; Professor & Coordinator of the Genodermatoses Sector of the Clinical Genetics Service at Federal University of Rio de Janeiro. Additionally, he is member of the clinical staff of Hospital Israelita Albert Einstein. Mauro Geller, MD, PhD, holds an MD degree from Teresopolis University Medical School, a PhD in Clinical Medicine from Federal University of Rio de Janeiro, and a Post-doc in Immunogenetics from Harvard University. He has extensive experience in the field of clinical immunology, especially in the areas of clinical medicine, tumoral immunology, genetics and immunodiagnostics. Dr. Geller is founding member and current medical director of the Brazilian National Neurofibromatosis Center; fellow of the American College of Physicians and of the Royal Society of Medicine; member of the European Society of Gene Therapy; and member of the Brazilian Societies of Immunology, Microbiology and Genetics. He is Board Certified in Internal Medicine, Immunology, Allergy and Public Health. Dr. Geller also has extensive experience with research in the areas of immunology, microbiology and genetics, as well as with clinical research, and has published 137 papers, 8 book chapters, and 4 books. He also serves as ad hoc advisor to the Brazilian National Institute of Health (ANVISA) and is member of the clinical staff of Hospital Israelita Albert Einstein.

PART 1 - STUDY TYPE DETERMINATION1. Epidemiological studies 2. Analytical studies 3. Summary

PART 2 - OBSERVATIONAL STUDIES 4. Determination of association strength between an exposure factor and an event in observational studies5. Increasing accuracy in observational studies

PART 3 - STEP-BY-STEP BIOSTATISTICS OF A CLINICAL TRIAL6. STEP 1: Investigator's hypothesis and expression of its corresponding outcome7. STEP 2: n estimation and n assessment of a published trial8. STEP 3: Organization of variables and endpoints9. STEP 4: Measures for results expression of a clinical trial10. STEP 5: Determination of normality or non-normality of data distribution 11. STEP 6: Hypothesis testing12. STEP 7: Correlating sample data with the general population - 95% confidence Interval

PART 4 - ADDITIONAL CONCEPTS IN BIOSTATISTICS13. Individual and collective benefit and risk indexes inferable from intervention cohort studies14. Statistical assessment of diagnostic tests for the clinic15. Systematic reviews and meta-analyses16. Correlation and regression17. Per protocol analysis and intention to treat analysis