Oncology Phase II trials with ordinal outcome

TitleOncology Phase II trials with ordinal outcome
Publication TypePresentation
Year of Publication2012
AuthorsIvanova, Anastasia
KeywordsSymposium II

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