Title | Oncology Phase II trials with ordinal outcome |
Publication Type | Presentation |
Year of Publication | 2012 |
Authors | Ivanova, Anastasia |
Keywords | Symposium II |
Abstract | Phase II trials in oncology are usually single arm studies to screen oncology treatments based on tumor response. Treatment response can be categorized into one of four types: complete response, partial response, stable disease and progressive disease. Investigators usually dichotomize responses in phase II trials and use a simple hypothesis regarding that binary outcome. We describe several novel design alternatives for Phase II trials with ordinal outcome. The designs can be generated using easy-to-use free software that can be found at http://cancer.unc.edu/biostatistics/program/ivanova |