Work

The rapid enrollment design for Phase I clinical trials

Year: 2016

Type: article

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.

Source: Statistics in Medicine

DOI: 10.1002/sim.6886

Authors: Anastasia Ivanova, Yunfei Wang, Matthew C. Foster

Institutions: University of North Carolina at Chapel Hill, Children's National, George Washington University, UNC Lineberger Comprehensive Cancer Center

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institutes of Health, National Cancer Institute