TABLE 2.

Benefits of CARRA-CoRe Compared With Traditional Product-Specific Registries

Characteristics of Consolidated Disease-Based Safety Registries	Benefits
Broad inclusion criteria allowing enrollment of all patients with specific diseases into a single registry	Larger sample sizes
	Inclusion of comparator groups
	More closely represents the target population
	Improved ability to detect serious and/or rare adverse events
	Systematic, active surveillance of adverse events and outcomes
	No competition for patients as occurs with multiple single-product registries
	Long-term retention of patients in registry as medication usage, age, and geographic location change
	Insight into how medications are actually used in the target population by practitioners
Consolidated safety registry infrastructure, standardized data entry and management, policies, procedures	Decreased variability in data entry, improving quality while limiting monitoring and data cleaning burden, and improving regulatory compliance
	Leverage existing rapid start agreements with sites, site performance training and regulatory processes, improving efficiency of study start-up and conduct
	Allows multiple concurrent safety surveillance projects for different products
	Long-term follow-up into adulthood improves assessment of events with long latency times
	Collaborative study design includes industry input while assuring scientific independence
	Standard of care outpatient visits and diagnostic studies decreases the registry’s cost per patient
	Ability to perform multiple concurrent projects of interest to stakeholders: investigators, industry partners, funding agencies, and patients
Comprehensive and cohesive scientific oversight platform for design and data analysis	Scientifically sound and efficient approach to meet post-marketing requirements and commitments for registries
	Improved assessment of the risk/benefit ratio of treatment options for patients, families, and providers
	Ability to compare multiple exposed and unexposed groups to more accurately analyze the strength of the association of adverse events to products
	Improved ability to understand contribution of disease course and severity to adverse events and outcomes
	Ability to incorporate patient- and family-centered goals and patient-reported outcomes
Engagement of patients and families in design and governance of the consolidated safety registry	Patients, families, and clinicians have input into the evaluation of the risk/benefit ratio of treatment options
	Improved patient and family trust in immunomodulatory products and the pharmaceutical industry owing to transparent governance and scientific oversight