Title | Phase II cancer clinical trials for biomarker-guided treatments. |
Publication Type | Journal Article |
Year of Publication | 2018 |
Authors | Jung, Sin-Ho |
Journal | J Biopharm Stat |
Volume | 28 |
Issue | 2 |
Pagination | 256-263 |
Date Published | 2018 |
ISSN | 1520-5711 |
Keywords | Biomarkers, Tumor, Clinical Trials, Phase II as Topic, Endpoint Determination, Humans, Medical Oncology, Molecular Targeted Therapy, Neoplasms, Probability, Research Design, Sample Size |
Abstract | The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint. |
DOI | 10.1080/10543406.2017.1372777 |
Alternate Journal | J Biopharm Stat |
Original Publication | Phase II cancer clinical trials for biomarker-guided treatments. |
PubMed ID | 28902567 |
PubMed Central ID | PMC5842127 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States |
Project: