Title | Practical designs for Phase I combination studies in oncology. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Wages, Nolan A., Anastasia Ivanova, and Olga Marchenko |
Journal | J Biopharm Stat |
Volume | 26 |
Issue | 1 |
Pagination | 150-66 |
Date Published | 2016 |
ISSN | 1520-5711 |
Keywords | Antineoplastic Combined Chemotherapy Protocols, Clinical Trials, Phase I as Topic, Dose-Response Relationship, Drug, Humans, Medical Oncology, Neoplasms, Research Design |
Abstract | Phase I trials evaluating the safety of multidrug combinations are becoming more common in oncology. Despite the emergence of novel methodology in the area, it is rare that innovative approaches are used in practice. In this article, we review three methods for Phase I combination studies that are easy to understand and straightforward to implement. We demonstrate the operating characteristics of the designs through illustration in a single trial, as well as through extensive simulation studies, with the aim of increasing the use of novel approaches in Phase I combination studies. Design specifications and software capabilities are also discussed. |
DOI | 10.1080/10543406.2015.1092029 |
Alternate Journal | J Biopharm Stat |
Original Publication | Practical designs for Phase I combination studies in oncology. |
PubMed ID | 26379085 |
PubMed Central ID | PMC4720553 |
Grant List | K25 CA181638 / CA / NCI NIH HHS / United States P01 CA142538 / CA / NCI NIH HHS / United States |
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