Methods and Biostatistics in Oncology

Raphael L. C. Araujo is a Surgical Oncologist specialized in the diagnosis and treatment of malignant and benign injuries of the liver, pancreas and colorectal liver metastases. He spent two years (2010 / 2012) as a Research Fellow at the Hepatopancreatobiliary Service of the Memorial Sloan-Kettering Cancer Center in New York (USA). During this time, he worked on clinical research of surgical and systemic treatment of pancreatic cancer and colorectal liver metastases. Afterwards, he also spent one year as a resident of the Hepatopancreatobiliary Service at the Hospital Paul Brousse, France (2012/2013). Dr. Araujo received a PhD and concluded his postdoctoral research in Gastroenterology from the University of São Paulo School of Medicine, the same institution where he worked for 2 years as an attending physician in the Liver Surgery Unit. He is currently head of the Department of Upper Gastrointestinal and Hepato-Pancreato-Biliary Surgery and Professor of the Post Graduation Program of Barretos Cancer Hospital, Barretos, São Paulo, Brazil, and Scientific Director of Brazilian Society of Surgical Oncology. Rachel P. Riechelmann is a medical oncologist and researcher in the field of gastrointestinal cancers. She completed her formal training and PhD at the Federal University of Sao Paulo, followed by a clinical research fellowship at Princess Margaret Hospital, University of Toronto, Canada. She is currently the Director of the Department of Oncology at AC Camargo Cancer Center, which is one of the largest academic cancer centers in Brazil and Latin America, and Research Director of the Brazilian Gastrointestinal Tumors Group. Research- wise, her areas of interest and expertise are GI malignancies and Neuroendocrine Tumors as well as Methodology of Clinical Research. She has 78 publications in peer-reviewed journals and several PhD students and oncology fellows conducting projects under her supervision.

Preface.- Introduction.- 1. Background of scientific method in oncology.- 2. Writing a hypothesis for a oncology study.- 3. Type of variables and distributions.- 4. Testing measures of association.- 5. Sample size calculation for oncology trials.- 6. Uni and multivariate analysis (understanding of regressions) in cancer research.- 7. Survival analyses in cancer trials.- 8. The role of transversal and cohort studies in oncology.- 9. Design of retrospective and case-control studies in oncology.- 10. Minimizing differences by randomization.- 11. How to design phase I trials in oncology.- 12. The many different designs of phase II oncology trials.- 13. Superiority and non-inferiority phase III oncology trials.- 14. Phase IV oncology trials.- 15. Analysis of graphs in clinical cancer research.- 16. Identifying biases in clinical cancer research.- 17. Ethics in clinical cancer research.- 18. Cost-effectiveness studies in oncology.- 19. How to undertake outcomes research in oncology.- 20. Systematic review and meta-analysis of oncology studies.- 21. Meta-research in oncology.- 22. Analysis of quality of life and patient-reported outcomes in oncology.- Exercises.- Commented answers.- Glossary.- Remissive index.