Translational Gastroenterology

Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.Dr Liu obtained his PhD in Biostatistics from the University of Pennsylvania. Dr Liu is Associate Professor of Biostatistics and Director of the Brown ARCH Data and Statistics Core. He also is a faculty member at the biostatistics core of the Lifespan/Boston/Brown Center for AIDS Research (CFAR), Brown Data Science Initiative (DSI), Advance-Clinical Translational Research (Advance-CTR) and an affiliated faculty member for the AMPATH Biostatistics and Data Program. His research interests are in the area of health data science and include clinical decision making, incomplete data problems, causal inference, diagnostic testing, and design of clinical trials. Devendra Mehta is a Pediatric Gastroenterologist, Director of the Translational GI Laboratory at Orlando Health Arnold Palmer Children’s Hospital, and the program director of the Pediatric GI and Nutrition Fellowship. He underwent training at St Thomas’ Hospital, now part of Kings College in London, UK, in Medicine, with further training at the Hospital for Sick Children, Toronto, Guys Hospital, London, UK, London School of Tropical Medicine and Hygiene (MSc Distinction) and Hahnemann University, Philadelphia for the Pediatric GI Fellowship. He has a special interest in developing biomarkers to aid the diagnostics of disorders and has studied a wide array of disorders including aspiration, Gastroesophageal reflux disease, Eosinophilic esophagitis, Helicobacter Pylori infection, Celiac Disease, Small bowel microbial overgrowth, Inflammatory Bowel Disease, Irritable Bowel Syndrome and Constipation, and produced many abstracts, presentations, papers and chapters in books. He directs and studies the integrative medicine clinic which uses Yoga and Meditation for chronic disorders, and the regional Feeding difficulty center. He has been recognized as a “Best Doctor” consistently and is on the board, and former President, of Central Florida Child Health Program, Inc., a non-profit organization. He has further responsibilities in research as the Chair of the Research Advisory Committee to help optimize studies and as faculty for the Biostatistics program for fellows. He has two patents and continues to work in national collaboratives such as in childhood and adult pancreatic disorders and Inflammatory Bowel Disease.Karoly Horvath, M.D., Ph.D. has been pediatric gastroenterologist since 1980. He graduated and received his Ph.D. degree in Hungary. Since 1990 he has been worked in US in a few academic medical centers, including the Hahnemann University in, Philadelphia, the University of Maryland at Baltimore, A.I duPont Hospital for Children affiliated to Jefferson Medical University and finally at Arnold Plamer Hospital for children. His commitment to education is shown that he established two successful pediatric gastroenterology training programs. First at University of Maryland in 2000 and the second at the Orlando Health in 2011. His research is mainly translational in nature. He founded a CLIA certified Pediatric Gastroenterology Specialty Laboratory 1993 that introduced unique clinical tests and assisted to set and other one In Delaware. He has 102 peer-reviewed publications, 31 book chapters, he has over 5000 citations, presented 54 invited lectures and author and coeditor of Pediatric Gastroenterology book.

• PART I: CONCEPT1. Introduction to clinical research2. The question3. Study population4. Outcome measurementsPART II: STUDY TYPES5. Design principles6. Case series7. Case-control study8. Cohort study9. Cross-section study10. Clinical trials11. Meta-analysis12. Cost-effectiveness study13. Diagnostic test evaluation14. Reliability study15. Database studies16. Surveys and questionnaires17. Qualitative methods and mixed methods Definition of the study typePART III: CLINICAL TRIALS17. Randomized control18. Nonrandomized control19. Historical control20. Cross-over21. Withdrawal studies22. Factorial design23. Group allocation24. Hybrid design25. Large, pragmatic26. Equivalence and noninferiority27. Adaptive28. Randomization30. Multicenter considerations Study design and practical considerationsPART IV: PLANNING31. Optimizing the question32. Meaningful outcome measurements  33. Sample size Power analysis34. Budgeting Funding, timeline, personnel, materials35. Ethics and review boards 36. Regulatory considerations for new drugs and devices 37. Funding approaches  38. Research team 39. Subject recruitment  40. Data management  41. Quality control  42. Report forms43. Subject adherence  44. Survival analysis  45. Monitoring committee in clinical trialsPART V: STATISTICAL PRINCIPLES46. Presenting data  47. Common issues in analysis  48. Basic statistical principles  49. Distributions Description, examples, implications in analysis. 50. Hypotheses and error types  51. Power Detecting effects52. Regression Explanation53. t-test Explanation54. Chi-square Explanation55. Analysis of variance Explanation56. Correlation Explanation57. Biases