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
Clinical Trial
. 2013 Aug;66(8 Suppl):S130-7.
doi: 10.1016/j.jclinepi.2013.02.015.

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus

Affiliations
Clinical Trial

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus

Jason T Connor et al. J Clin Epidemiol. 2013 Aug.

Abstract

Objective: We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping.

Study design and setting: The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design.

Results: The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment.

Conclusion: When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size.

Keywords: Adaptive sample size; Bayesian adaptive trials; Comparative effectiveness research; Emergency medicine; Response adaptive randomization; Status epilepticus.

PubMed Disclaimer

References

    1. Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS. Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change. Annals of Internal Medicine. 2009;151:206–209. - PubMed
    1. Chalkidou K, Tunis S, Whicher D, Fowler R, Zwarenstein M. The Role for Pragmatic Randomized Controlled Trials (pRCTs) in Comparative Effectiveness Research Clinical Trials. 2012 In press. - PubMed
    1. Sox HC, Goodman SN. The Methods of Comparative Effectiveness Research. Annual Review of Public Health. 2012;33:425–445. - PubMed
    1. Meurer MJ, Lewis RJ, Tagle D, Fetters MD, Legocki L, Berry S, Connor J, Durkalski V, Elm J, Zhao W, Frederiksen S, Silbergleit R, Palesch Y, Berry DA, Barsan WG. An Overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Project. Annals of Emergency Medicine. In press. - PMC - PubMed
    1. Berry DA. Adaptive clinical trials: the promise and the caution. Journal of Clinical Oncology. 2011;29:606–609. - PubMed

Publication types

MeSH terms