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Design of Phase II Non-inferiority Trials.

Publication ,  Journal Article
Jung, S-H
Published in: Contemp Clin Trials Commun
September 2017

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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Published In

Contemp Clin Trials Commun

DOI

ISSN

2451-8654

Publication Date

September 2017

Volume

7

Start / End Page

23 / 27

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences
 

Citation

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Jung, S.-H. (2017). Design of Phase II Non-inferiority Trials. Contemp Clin Trials Commun, 7, 23–27. https://doi.org/10.1016/j.conctc.2017.04.008
Jung, Sin-Ho. “Design of Phase II Non-inferiority Trials.Contemp Clin Trials Commun 7 (September 2017): 23–27. https://doi.org/10.1016/j.conctc.2017.04.008.
Jung S-H. Design of Phase II Non-inferiority Trials. Contemp Clin Trials Commun. 2017 Sep;7:23–7.
Jung, Sin-Ho. “Design of Phase II Non-inferiority Trials.Contemp Clin Trials Commun, vol. 7, Sept. 2017, pp. 23–27. Pubmed, doi:10.1016/j.conctc.2017.04.008.
Jung S-H. Design of Phase II Non-inferiority Trials. Contemp Clin Trials Commun. 2017 Sep;7:23–27.
Journal cover image

Published In

Contemp Clin Trials Commun

DOI

ISSN

2451-8654

Publication Date

September 2017

Volume

7

Start / End Page

23 / 27

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences