Title

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

Authors

Authors

J. T. Connor; J. J. Elm; K. R. Broglio;Esett Adapt-It Investigators

Comments

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Abbreviated Journal Title

J. Clin. Epidemiol.

Keywords

Comparative effectiveness research; Bayesian adaptive trials; Response; adaptive randomization; Adaptive sample size; Status epilepticus; Emergency medicine; PHARMACEUTICAL PRODUCT DEVELOPMENT; CLINICAL-TRIALS; DESIGNS; Health Care Sciences & Services; Public, Environmental & Occupational; Health

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. (C) 2013 Elsevier Inc. All rights reserved.

Journal Title

Journal of Clinical Epidemiology

Volume

66

Issue/Number

8

Publication Date

1-1-2013

Document Type

Article

Language

English

First Page

S130

Last Page

S137

WOS Identifier

WOS:000322207400017

ISSN

0895-4356

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