Simulating Clinical Trials With and Without Intracranial EEG Data.
Daniel M Goldenholz, Joseph J Tharayil, Rubin Kuzniecky, Philippa Karoly, William H Theodore, Mark J Cook
Epilepsia Open | Wiley | Published : 2017
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 achie..View full abstract