How many patients do you need? Investigating trial designs for anti-seizure treatment in acute brain injury patients.
Harsh ParikhHaoqi SunRajesh AmerineniEric S RosenthalAlexander VolfovskyCynthia RudinM Brandon WestoverSahar F ZafarPublished in: Annals of clinical and translational neurology (2024)
Our simulations using drug efficacy show sample sizes are infeasible, even for potentially unethical placebo-control trials. We highlight the strength of simulations with observational data to inform the null hypotheses and propose use of this simulation-based RCT paradigm to assess the feasibility of future trials of anti-seizure treatment in acute brain injury.
Keyphrases
- brain injury
- end stage renal disease
- subarachnoid hemorrhage
- newly diagnosed
- ejection fraction
- chronic kidney disease
- cerebral ischemia
- peritoneal dialysis
- prognostic factors
- clinical trial
- molecular dynamics
- emergency department
- drug induced
- study protocol
- hepatitis b virus
- electronic health record
- phase iii
- patient reported outcomes
- extracorporeal membrane oxygenation
- phase ii
- adverse drug
- data analysis
- temporal lobe epilepsy
- finite element analysis