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: The Investigator's Hypothesis 1. Investigator's Hypothesis and Expression of its Corresponding Outcome

Part 2: Collective Health 2. Disease Frequency Measures 3. Health Indicators 4. Epidemiological Studies 5. Pharmacoeconomics

Part 3: Observational Studies 6. Basic Concepts in Observational Studies 7. Determination of Association Strength Between an Exposure Factor and an Event in Observational Studies 8. Increasing Accuracy in Observational Studies

Part 4: Biostatistics of Intervention Studies - The Clinical Trials 9. The Intervention Studies 10. N Estimation and N Assessment of a Published Trial 11. Organization of Variables and Endpoints 12. Measures for Results Expression of a Clinical Trial 13. Determination of Normality or Non-Normality of Data Distribution 14. Hypothesis Testing 15. Correlating Sample Data with the General Population - 95% Confidence Interval Summarizing the Steps

Part 5: Additional Concepts in Biostatistics 16. Individual and Collective Benefit and Risk Indexes Inferable from Intervention Studies 17. Statistical Assessment of Diagnostic Tests for the Clinic 18. Systematic Reviews and Meta-Analyses 19. Correlation and Regression 20. Per Protocol Analysis and Intention-to-Treat Analysis