Simulating Clinical Trials With and Without Intracranial EEG Data.

ABSTRACT:

Objective

It is currently unknown if knowledge of clinically silent (electrographic) seizures improves the statistical efficiency of clinical trials.

Methods

Using data obtained from 10 patients with chronically implanted subdural electrodes over an average of 1 year, a Monte Carlo bootstrapping simulation study was performed to estimate the statistical power of running a clinical trial based on A) patient reported seizures with intracranial EEG (icEEG) confirmation, B) all patient reported events, or C) all icEEG confirmed seizures. A "drug" was modeled as having 10%, 20%, 30%, 40% and 50% efficacy in 1000 simulated trials each. Outcomes were represented as percentage of trials that achieved p<0.05 using Fisher Exact test for 50%-responder rates (RR50), and Wilcoxon Rank Su

SUBMITTER: Goldenholz DM 

PROVIDER: S-EPMC5526639 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature