The rapid enrollment design for Phase I clinical trials.

TitleThe rapid enrollment design for Phase I clinical trials.
Publication TypeJournal Article
Year of Publication2016
AuthorsIvanova, Anastasia, Yunfei Wang, and Matthew C. Foster
JournalStat Med
Volume35
Issue15
Pagination2516-24
Date Published2016 07 10
ISSN1097-0258
KeywordsClinical Trials, Phase I as Topic, Dose-Response Relationship, Drug, Humans, Maximum Tolerated Dose, Medical Oncology, Patient Selection, Research Design
Abstract

We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend always using a safety rule in any fast accruing dose-finding trial. Copyright © 2016 John Wiley & Sons, Ltd.

DOI10.1002/sim.6886
Alternate JournalStat Med
Original PublicationThe rapid enrollment design for Phase I clinical trials.
PubMed ID26833922
PubMed Central IDPMC4892992
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States
P30 CA016086 / CA / NCI NIH HHS / United States
R01 CA120082 / CA / NCI NIH HHS / United States