Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

TitleNine-year change in statistical design, profile, and success rates of Phase II oncology trials.
Publication TypeJournal Article
Year of Publication2016
AuthorsIvanova, Anastasia, Barry Paul, Olga Marchenko, Guochen Song, Neerali Patel, and Stergios J. Moschos
JournalJ Biopharm Stat
Volume26
Issue1
Pagination141-9
Date Published2016
ISSN1520-5711
KeywordsAntineoplastic Agents, Clinical Trials, Phase II as Topic, Data Interpretation, Statistical, Humans, Medical Oncology, Neoplasms
Abstract

We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.
DOI10.1080/10543406.2015.1092030
Alternate JournalJ Biopharm Stat
Original PublicationNine-year change in statistical design, profile, and success rates of Phase II oncology trials.
PubMed ID26368744
PubMed Central IDPMC5995106
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States
Project: 
Project 2.1