Phase II cancer clinical trials for biomarker-guided treatments.

TitlePhase II cancer clinical trials for biomarker-guided treatments.
Publication TypeJournal Article
Year of Publication2018
AuthorsJung, Sin-Ho
JournalJ Biopharm Stat
Volume28
Issue2
Pagination256-263
Date Published2018
ISSN1520-5711
KeywordsBiomarkers, 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.

DOI10.1080/10543406.2017.1372777
Alternate JournalJ Biopharm Stat
Original PublicationPhase II cancer clinical trials for biomarker-guided treatments.
PubMed ID28902567
PubMed Central IDPMC5842127
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States