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

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

Journal of clinical epidemiology (2013-07-17)
Jason T Connor, Jordan J Elm, Kristine R Broglio
ABSTRACT

We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. 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. When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size.

MATERIALS
Product Number
Brand
Product Description

Supelco
Phenytoin, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
5,5-Diphenylhydantoin, ≥98%
Supelco
Valproic acid solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Supelco
Levetiracetam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Sigma-Aldrich
Levetiracetam, ≥98% (HPLC)
Supelco
Phenytoin solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Levetiracetam, European Pharmacopoeia (EP) Reference Standard
Phenytoin, European Pharmacopoeia (EP) Reference Standard
Phenytoin for system suitability, European Pharmacopoeia (EP) Reference Standard
Supelco
Valproic acid, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Piracetam
Sigma-Aldrich
2-Propylpentanoic acid
Levetiracetam impurity D, European Pharmacopoeia (EP) Reference Standard