A5072555468- Statistical Methods in Clinical Trials
- Pharmacovigilance and Adverse Drug Reactions
- Health Systems, Economic Evaluations, Quality of Life
- Advanced Causal Inference Techniques
- Pregnancy and Medication Impact
- Vaccine Coverage and Hesitancy
- Influenza Virus Research Studies
- SARS-CoV-2 and COVID-19 Research
- Meta-analysis and systematic reviews
- Electronic Health Records Systems
- Biosimilars and Bioanalytical Methods
- Reproductive Health and Contraception
- Diabetes Treatment and Management
- Ethics in Clinical Research
- Pharmaceutical Economics and Policy
- Herpesvirus Infections and Treatments
- HIV/AIDS Research and Interventions
- Medication Adherence and Compliance
- Statistical Methods and Bayesian Inference
- Blood Pressure and Hypertension Studies
- Advanced Statistical Process Monitoring
- Pregnancy and preeclampsia studies
- Pharmaceutical Practices and Patient Outcomes
- Jewish and Middle Eastern Studies
- Poxvirus research and outbreaks
Harvard Pilgrim Health Care
2016-2025
Harvard University
2016-2025
United States Food and Drug Administration
2017
Brigham and Women's Hospital
2017
Massachusetts Institute of Technology
2009-2013
Engineering Systems (United States)
2011
University of Pennsylvania
2009
A distributed health data network is a system that allows secure remote analysis of separate sets, each comprising different medical organization's or plan's records. Distributed networks are currently being planned could cover millions people, permitting studies comparative clinical effectiveness, best practices, diffusion technologies, and quality care. These also support assessment product safety other public needs. technologies allow holders to control all uses their data, which...
Objectives To examine valsartan, losartan and irbesartan usage switching patterns in the USA, UK, Canada Denmark before after July 2018, when first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled. Design Retrospective cohort study. Setting Canadian administrative healthcare data, Danish National Prescription Registry UK primary care electronic health records. Participants Patients aged 18 years older between January 2014 December 2020. Intervention Valsartan, irbesartan. Main...
Signal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging spontaneous reporting databases (SRDs), which represent cornerstone pharmacovigilance. However, exponentially increasing generation availability real-world collected in longitudinal healthcare (LHDs), along with rapid evolution artificial intelligence-based algorithms other advanced analytical methods, offers a wide range...
BACKGROUND AND OBJECTIVES In 2023, the Advisory Committee on Immunization Practices recommended either Abrysvo, a vaccine administered during pregnancy, or nirsevimab, monoclonal antibody to infants after birth, protect from respiratory syncytial virus (RSV). Our objective was assess proportion of immunized against RSV through antenatal vaccination receipt nirsevimab among linked pregnancy-infant dyads. METHODS Using data 10 Vaccine Safety Datalink health systems and validated algorithm, we...
To estimate real-world off-label use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, rates diabetic ketoacidosis (DKA), and compare them DKA observed sotagliflozin clinical trials.We identified initiators SGLT2 the Sentinel System from March 2013 to June 2018, determined prevalence diabetes using a narrow broad definition, measured administrative claims data. Standardized incidence ratios (SIRs) were calculated age- sex-specific follow-up time trials...
The tree-based scan statistic is a statistical data mining tool that has been used for signal detection with self-controlled design in vaccine safety studies. This disproportionality adjusts multiple testing evaluation of thousands potential adverse events. However, many drug questions are not well suited analysis. We propose method combines statistics propensity score–matched analysis new initiator cohorts, robust investigations safety. conducted plasmode simulations to evaluate...
Abstract The US Food and Drug Administration (FDA) Sentinel System uses a distributed data network, common model, curated real-world data, analytic tools to generate evidence for FDA decision-making. system needs include flexibility, transparency, reproducibility while protecting patient privacy. Based on over decade of experience, critical limitation is the inability identify enough medical conditions interest in observational satisfactory level accuracy. Improving system’s ability use...
The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement FDA Amendments Act of 2007 that agency establish system for monitoring risks associated with drug biologic products using data from disparate sources. has completed hundreds analyses, including many have directly informed regulatory decisions. also was designed support national infrastructure learning health system. governance guiding principles were facilitate Sentinel's role as resource. now...
The self-controlled tree-temporal scan statistic-a new signal-detection method-can evaluate whether any of a wide variety health outcomes are temporally associated with receipt specific vaccine, while adjusting for multiple testing. Neither nor postvaccination potential periods increased risk need be prespecified. Using US medical claims data in the Food and Drug Administration's Sentinel system, we employed method to adverse events occurring after quadrivalent human papillomavirus vaccine...
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The US Food and Drug Administration's Sentinel Innovation Center aimed to establish a query-ready, quality-checked distributed data network containing electronic health records (EHRs) linked with insurance claims for at least 10 million individuals expand the utility of real-world regulatory decision-making.
Abstract Purpose To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in Sentinel System (formerly Mini‐Sentinel Pilot), a Food Drug Administration‐sponsored national system that typically relies on data are mature, settled, updated quarterly. Methods Three Data Partners provided their earliest available (“fresh”) cumulative claims vaccination health outcomes 3–4 times staggered basis during 2013–2014 season,...
Human immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP) protects high risk patients from becoming infected with HIV. Clinicians need help to identify candidates for PrEP based on information routinely collected in electronic health records (EHRs). The greatest statistical challenge developing a prediction model is that acquisition extremely rare. Methods : Data consisted of 180 covariates (demographic, diagnoses, treatments, prescriptions) extracted 399 385 patient (150 cases)...
Abstract Purpose Identifying hospitalizations for serious infections among patients dispensed biologic therapies within healthcare databases is important post‐marketing surveillance of these drugs. We determined the positive predictive value (PPV) an ICD‐10‐CM‐based diagnostic coding algorithm to identify hospitalization infection therapy FDA's Sentinel Distributed Database. Methods identified health plan members who met following criteria: (1) hospital ICD‐10‐CM discharge diagnosis between...
Except for spontaneous reporting systems, vaccine safety monitoring generally involves pre-specifying health outcomes and post-vaccination risk windows of concern. Instead, we used tree-based data-mining to look more broadly possible adverse events after Pfizer-BioNTech, Moderna, Janssen COVID-19 vaccination.Vaccine Safety Datalink enrollees receiving ≥1 dose in 2020-2021 were followed 70 days Pfizer-BioNTech or Moderna 56 vaccination. Incident diagnoses inpatient emergency department...
The self-controlled tree-temporal scan statistic allows detection of potential vaccine- or drug-associated adverse events without prespecifying the specific postexposure risk intervals concern. It thus opens a promising new avenue for safety studies. method has been successfully used to evaluate 2 vaccines adolescents and young adults, but its suitability study older adults had not established. present applied assess live attenuated herpes zoster vaccination during 2011-2017 in US aged ≥60...
Parents indicate that safety is their top concern about human papillomavirus (HPV) vaccination. A data-mining method not requiring prespecification of health outcome(s) or postexposure period(s) potentially increased risk can be used to identify possible associations between an exposure and any thousands medically attended outcomes; this was applied data on the 9-valent HPV vaccine (HPV9) detect potential problems. Data 9- 26-year-olds who had received HPV9 November 4, 2016, August 5, 2018,...
The recombinant herpes zoster vaccine (RZV), approved as a 2-dose series in the United States October 2017, has proven highly effective and generally safe. However, small risk of Guillain-Barré syndrome after vaccination was identified approval, questions remain about other possible adverse events. This data-mining study assessed RZV safety using self-controlled tree-temporal scan statistic, scanning data on thousands diagnoses recorded during follow-up to detect any statistically unusual...
Congress mandated the creation of a postmarket Active Risk Identification and Analysis (ARIA) system containing data on 100 million individuals for monitoring risks associated with drug biologic products using from disparate sources to complement US Food Drug Administration's (FDA's) existing capabilities. We report first 6 years ARIA utilization in Sentinel System (2016-2021). The FDA has used evaluate 133 safety concerns; 54 these evaluations have closed regulatory determinations, whereas...
Abstract Purpose Our objective is to describe how the U.S. Food and Drug Administration (FDA)'s Sentinel System implements best practices ensure trust in drug safety studies using real‐world data from disparate sources. Methods We present a stepwise schematic for Sentinel's harmonization, quality check, query design implementation, reporting practices, approaches enhancing transparency, reproducibility, replicability of at each step. Conclusions Each partner converts its source into Common...
Abstract We conducted retrospective public health surveillance using data from 2006 to 2016 in seven integrated delivery systems FDA’s Sentinel System. identified pediatric hypertensive patients by clinical and claims-based definitions compared demographics, baseline profiles follow-up time profiles. Among 3,757,803 aged 3 17 years, we 781,722 children 551,246 teens with at least three blood pressure measures over 36-months. Of these, 70,315 (9%) 47,928 (8.7%) met the definition for...