Registries vs. Randomized Clinical Trials

Characteristic	Versus Randomized Controlled Clinical Trial (RCT)
Treatment	Evaluate care in real-world setting
Time Period/Duration	Long-term outcomes collected
Patients	Can involve large numbers of patients; "typical" patients seen in real-world setting Limited inclusion/exclusion criteria
Methods	Do not require comparator/placebo; "typical" care Open-label; no defined/mandated interventions or data collection No random allocation of patients
Statistical Analysis and Data Collection	Hypothesis generating; no sample size calculation; focus on "generalizeability"/heterogeneous patients
Patient Consent and Ethics Review	Focus on handling of personal health information and not risk
Safety	Voluntary reporting of adverse events Unsolicited (vs. solicited) adverse event collection



Limited number of subjects Study subjects are homogeneous Homogeneity among limited investigative sites Tight inclusion/exclusion criteria Limited information Safety and efficacy data Prospective		Unlimited number of subjects Study subjects are heterogeneous Heterogeneity among numerous investigative sites All subjects on therapy / open view Macro and micro level view Safety and effectiveness data Prospective or retrospective

Patient Registries represent a unique and powerful method for the collection of observational, epidemiologic, and clinical data whereby accelerating innovation, producing faster knowledge gains, improving awareness of patient outcomes, and providing a clearer understanding of a therapy's' impact on patients' quality of life.