Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Nov;45(Pt A):69-75.
doi: 10.1016/j.cct.2015.06.013. Epub 2015 Jun 26.

The futility study--Progress over the last decade

Bruce Levin  1
Affiliations

The futility study--Progress over the last decade

Bruce Levin. Contemp Clin Trials. 2015 Nov.

Abstract

We review the futility clinical trial design (also known as the non-superiority design) with respect to its emergence and methodologic developments over the last decade, especially in regard to its application to clinical trials for neurological disorders. We discuss the design's strengths as a programmatic screening device to weed out unpromising new treatments, its limitations and pitfalls, and a recent critique of the logic of the method.

Keywords: Futility design; Non-superiority design; Phase II trials; Screening program.

PubMed Disclaimer

References

    1. Gehan EA. The determination of teh number of patients required in a preliminary and a follow-up trial of a new chmotherapeutic agent. J Chronic Dis. 1961;13:346–53. - PubMed
    1. Herson J. Predictive probability early termination plans for phase II clinical trials. Biometrics. 1979;35:775–83. - PubMed
    1. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143–51. - PubMed
    1. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1–10. - PubMed
    1. Betensky R. Alternative derivations of a rule for early stopping in favor of H0. The Amer Statistician. 2000;54:35–9.

Publication types

MeSH terms

LinkOut - more resources