Title | The rapid enrollment design for Phase I clinical trials. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Ivanova, Anastasia, Yunfei Wang, and Matthew C. Foster |
Journal | Stat Med |
Volume | 35 |
Issue | 15 |
Pagination | 2516-24 |
Date Published | 2016 Jul 10 |
ISSN | 1097-0258 |
Keywords | Clinical 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. |
DOI | 10.1002/sim.6886 |
Alternate Journal | Stat Med |
Original Publication | The rapid enrollment design for Phase I clinical trials. |
PubMed ID | 26833922 |
PubMed Central ID | PMC4892992 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States P30 CA016086 / CA / NCI NIH HHS / United States R01 CA120082 / CA / NCI NIH HHS / United States |
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