Overview of FDA s active surveillance programs and epidemiologic studies for vaccines
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1 Overview of FDA s active surveillance programs and epidemiologic studies for vaccines David Martin, M.D., M.P.H. Director, Division of Epidemiology Center for Biologics Evaluation and Research Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines June 3,
2 VAERS Prelicensure safety data Medical Literature Other sources Data Mining Signal detection Active Surveillance Signal refinement Signal evaluation: hypothesis testing in a formal pharmacoepidemiologic study 2
3 Routine Pharmacovigilance All-inclusive surveillance for all vaccines conducted by both the US FDA and sponsors Continuous safety monitoring with passive surveillance The Vaccine Adverse Event Reporting System (VAERS) is co-managed by FDA and CDC Disproportionality analyses of spontaneous reports Periodic safety update reports (PSURs) Signal detection, issue evaluation, labeling updates Medical literature review Contact with international public health and regulatory agencies 3 3
4 Epidemiology, Sept
5 FDA Amendments Act of 2007 Pharmacovigilance Pre-FDAAA Passive surveillance Ad hoc analytic studies Voluntary commitments for postmarketing studies Post-FDAAA Active surveillance of 100 million individuals by 2012 Authority to require postmarketing studies Communication Negotiated label changes Risk communication discretionary Authority to require label changes based on new safety information Quarterly publication of potential safety signals Published conclusions from an 18-month post-approval safety review Risk Mitigation Negotiated RiskMAP (risk minimization action plan) Authority to require REMS (Risk Evaluation and Mitigation Strategies) to ensure that benefits outweigh risks 5
6 Components of the Sentinel Initiative Sentinel Initiative Public-private partnership OMOP* Brookings Institution Mini-Sentinel Collaboration of data partners, academia, non-profit organizations Covers all FDA regulated medical products Federal Partners Collaboration Department of Defense (DoD) Department of Veterans Affairs (VA) Centers for Medcare & Medicaid Services (CMS) Postlicensure Rapid Immunization Safety Monitoring program (PRISM) Blood Safety Continuous Active Surveillance Network (Blood-SCAN) * Observational Medical Outcomes Partnership 6 6
7 5 Year Mini-Sentinel Pilot Infrastructure Integration Sept 2009 Sept 2014 Nov 2011 (Month 27/60) - Governance - Common data model - Data partnerships - Distributed database - Queries - First protocols Innovation & collaboration - Augment not replace existing systems - Increase transparency of results - Incorporate Sentinel into FDA routines Transition & reconfiguration 7
8 Comprised of quality-checked data held by 17 partner organizations 99 million individuals (July 2011) accessible through a distributed database Provides FDA with the capability to address potential safety concerns with most regulated medical products in a timely fashion Summary tables: prevalence information for products and diagnoses Modular programs: produce crude rates in order to refine signals Protocol based evaluations: Predefined algorithms to identify exposures, outcomes, comparators with standardized confounding control Advantages Helps prioritize safety signals, informs next step (full epi study) Conserves finite resources for protocol development, programming, and chart review Decreases start up time (no customized protocol/programming) 8
9 Basic Distributed Database Model Privacy Firewall Health Plan 1 Health Plan 2 Informatics (e.g. SAS code) Epidemiologic and statistical study design Management Health Plan 3 Coordinating Center Stakeholder Health Plan N 9 9
10 Basic Distributed Database Model Privacy Firewall Health Plan 1 Aggregate data transfer to ensure privacy Health Plan 2 Health Plan 3 Coordinating Center Stakeholder Health Plan N 10 10
11 Modular Programs Examples Frequency of incident events among members (with or without a pre-existing condition) exposed to a product Concomitant product use among members (with or without a preexisting condition) exposed to a product Potential uses Immediate next step after passive surveillance/data mining findings Estimate incidence rates of health outcomes of interest Provide reassurance by analyzing trends over time Enables FDA to prioritize safety issues 11
12 Framework Needed for Modular Programs Positive Predictive Value of Administrative Codes Exposure Outcome Complexity* High Low High Trends over time Not feasible Low Incorporate into routine pharmacovigilance Trends over time * Numerous factors affect level of complexity including ease of measuring and controlling for confounding, availability of medical records, accuracy of documentation in medical records, etc. 12
13 Postlicensure Rapid Immunization Safety Monitoring System (PRISM) Integral part of Mini-Sentinel dedicated to vaccine safety Claims based system with over 40 million individuals Four national health plans: Aetna, HealthCore (Wellpoint), Humana, OptumInsight (United Healthcare) Linkages to eight vaccine registries: Florida, Michigan, Minnesota, New York, Pennsylvania, Virginia, Wisconsin, New York City Limited access to medical records Infrastructure and methods development Evidence reviews for key health outcomes Operational framework Identification of signals without pre-specified outcomes Sequential analysis of data using propensity scores to control for confounding 13
14 PRISM Surveillance Evaluations Three vaccine safety evaluations underway Rotavirus vaccines and intussusception Human papillomavirus vaccine and venous thromboembolism Seasonal trivalent influenza vaccine and febrile seizures Methodological highlights Self controlled risk interval design developed in the Vaccine Safety Datalink Vaccine exposure data enhanced by vaccine registry data Exposures and outcomes will be chart validated An evaluation of pregnancy outcomes after trivalent influenza vaccine is currently being planned 14
15 Medicare beneficiaries 38 million persons age >65 years 8 million persons age <65 with disability or end stage renal disease Near real-time surveillance Active surveillance for signal detection Conducted for GBS after influenza vaccination in 2009, 2010, and 2011 Epidemiologic studies Evaluation of GBS after H1N1 vaccine using medical record review data Methodological studies Refinement of methodologies to conduct vaccine safety assessment Examples: Alpha spending to take into account multiple testing, adjust for delay in claims 15
16 Other Federal Partners Address populations that might be under-represented in other systems US Department of Defense H1N1 end of season analysis Planned study of Idiopathic Thrombocytopenic Purpura following live vaccines US Department of Veterans Affairs H1N1 end of season analysis seasonal influenza vaccine end of season analysis Planned study of Zoster vaccine Indian Health Service H1N1 end of season analysis Access to medical records for diagnosis verification and hypothesis confirmation Over 1,000,000 beneficiaries in each dataset 16
17 U.S. CDC Vaccine Safety Datalink Ten geographically diverse health maintenance organizations that participate in a large linked database representing approximately 3% of U.S. population Surveillance and Hypothesis testing studies can be conducted Vaccination (exposure) Outpatient, emergency department, hospital and laboratory coding data (health outcomes) Demographic variables (confounders) Accessible medical chart review 17
18 Summary Routine pharmacovigilance is currently performed for over 70 US licensed vaccines FDAAA 2007 prioritizes safety throughout the product lifecycle by placing additional emphasis on postmarketing data acquisition and use in the regulatory decision making process Population-based surveillance and epidemiologic study capabilities have expanded significantly Mini Sentinel and the federal partners cover a large segment of the US population The volume and variety of FDA medical products exceeds the resources available for pre-planned evaluations; MiniSentinel modular programs are a general purpose risk refinement tool designed to address this gap Infrastructure and methods development for population based pharmacovigilance/pharmacoepidemiologic tools is ongoing 18 18
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