Design Issues in Comparative Effectiveness Research
Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus

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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

Comparative effectiveness research
Bayesian adaptive trials
Response adaptive randomization
Adaptive sample size
Status epilepticus
Emergency medicine

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Conflict of interest: The authors have no conflicts of interest related to the content of this article.