Title | Seamless Phase IIa/IIb and enhanced dose-finding adaptive design. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Yuan, Jiacheng, Herbert Pang, Tiejun Tong, Dong Xi, Wenzhao Guo, and Peter Mesenbrink |
Journal | J Biopharm Stat |
Volume | 26 |
Issue | 5 |
Pagination | 912-23 |
Date Published | 2016 |
ISSN | 1520-5711 |
Keywords | Clinical Trials, Phase II as Topic, Dose-Response Relationship, Drug, Drug Design, Humans, Probability, Research Design, Sample Size |
Abstract | In drug development, when the drug class has a relatively well-defined path to regulatory approval and the enrollment is slow with certain patient populations, one may want to consider combining studies of different phases. This article considers combining a proof of concept (POC) study and a dose-finding (DF) study with a control treatment. Conventional DF study designs sometimes are not efficient, or do not have a high probability to find the optimal dose(s) for Phase III trials. This article seeks more efficient DF strategies that allow the economical testing of more doses. Hypothetical examples are simulated to compare the proposed adaptive design vs. the conventional design based on different models of the overall quantitative representation of efficacy, safety, and tolerability. The results show that the proposed adaptive design tests more active doses with higher power and comparable or smaller sample size in a shorter overall study duration for POC and DF, compared with a conventional design. |
DOI | 10.1080/10543406.2015.1094807 |
Alternate Journal | J Biopharm Stat |
Original Publication | Seamless phase IIa/IIb and enhanced dose-finding adaptive design. |
PubMed ID | 26390951 |
PubMed Central ID | PMC5025390 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States |
Seamless Phase IIa/IIb and enhanced dose-finding adaptive design.
Project: