Title | Design of Phase II Non-inferiority Trials. |
Publication Type | Journal Article |
Year of Publication | 2017 |
Authors | Jung, Sin-Ho |
Journal | Contemp Clin Trials Commun |
Volume | 7 |
Pagination | 23-27 |
Date Published | 2017 Sep |
ISSN | 2451-8654 |
Abstract | With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials. |
DOI | 10.1016/j.conctc.2017.04.008 |
Alternate Journal | Contemp Clin Trials Commun |
Original Publication | Design of phase II non-inferiority trials. |
PubMed ID | 28798964 |
PubMed Central ID | PMC5546322 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States |
Design of Phase II Non-inferiority Trials.
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