Table 4

Dynamic AED Registry in context of FDA approval process for medical devices

	Premarket		Hybrid	Postmarket
	Premarket		Dynamic AED Registry
	Phase I	Phase II	Phase III	Postapproval	Postmarket	Clinical registry
Aim	Safety	Efficacy	Safety, efficacy and effectiveness		Effectiveness
Inclusion criteria	Restrictive		Either	Broad
Intervention	Tight protocol		Either	Implemented in usual clinical practice
Cointervention	Based on protocols for many aspects of care		Either	Based on local practice; monitored but minimal control
Adherence to protocol	Required		Either	Expected and considered in sample size and analysis plan
Events	Related to biological effect (eg, conversion out of shockable rhythm)		Either		Related to patient outcome (eg, survival)
Analysis	Treatment received		Both	Intention to treat
Sample size	Usually <1000		Either		Usually > 1000
Data burden	Large		Core supplemented by study-specific	Minimal and simple core
Study management	Significant interventions and support from research staff		Minimal support and interventions from research team