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Design of Phase II Non-inferiority Trials
#MMPMID28798964
Jung SH
Contemp Clin Trials Commun
2017[Sep]; 7
(?): 23-27
PMID28798964
show ga
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.
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