A5036429950- Pharmacovigilance and Adverse Drug Reactions
- Influenza Virus Research Studies
- Vaccine Coverage and Hesitancy
- Statistical Methods in Clinical Trials
- SARS-CoV-2 and COVID-19 Research
- Biomedical Text Mining and Ontologies
- Computational Drug Discovery Methods
- Health Systems, Economic Evaluations, Quality of Life
- Peripheral Neuropathies and Disorders
- Bacillus and Francisella bacterial research
- Animal Nutrition and Physiology
- Viral gastroenteritis research and epidemiology
- Academic integrity and plagiarism
- Heparin-Induced Thrombocytopenia and Thrombosis
- Pharmaceutical studies and practices
- Ethics in Clinical Research
- Biosimilars and Bioanalytical Methods
- Bacterial Infections and Vaccines
- Viral Infections and Immunology Research
- Healthcare cost, quality, practices
- Hepatitis B Virus Studies
- Topic Modeling
- Herpesvirus Infections and Treatments
- Animal Virus Infections Studies
- Food Allergy and Anaphylaxis Research
Center for Drug Evaluation and Research
2016-2025
United States Food and Drug Administration
2014-2024
University of Minnesota
2020-2024
Weber State University
2015-2023
American Society of Safety Professionals
2023
Food and Drug Administration
2005-2022
University of Minnesota System
2020
Waterford Institute
2019
Union Presbyterian Seminary
2019
Center for Biologics Evaluation and Research
2007-2017
In May 2008, the Department of Health and Human Services announced launch Sentinel Initiative by US Food Drug Administration (FDA) to create System, a national electronic system for medical product safety surveillance.1, 2 This complements existing FDA surveillance capabilities that track adverse events reported after use regulated products allowing proactively assess these products.
A decade after the launch of FDA Sentinel Initiative, it has matured from a pilot program designed to assess potential drug-safety signals in insurance claims into core component agency's evolving safety surveillance system.
This report proposes a stepwise process covering the range of considerations to systematically consider key choices for study design and data analysis non-interventional studies with central objective fostering generation reliable reproducible evidence. These steps include (1) formulating well defined causal question via specification target trial protocol; (2) describing emulation each component protocol identifying fit-for-purpose data; (3) assessing expected precision conducting...
The mission of the US Food and Drug Administration (FDA) is to protect promote public health. FDA does this by ensuring safety, efficacy, quality human drugs, biological products, medical devices as well other FDA-regulated products. also responsible for making sure that has access accurate, comprehensible science-based information optimal use Postmarket safety surveillance—monitoring products once they reach marketplace—is key these efforts. For decades, relied primarily on spontaneous...
BACKGROUND. In 1999, a previous rotavirus vaccine (RotaShield; Wyeth Laboratories, Marietta, PA) was withdrawn from the US market after postlicensure monitoring identified an association with intussusception. Although new (RotaTeq; Merck, West Point, introduced in 2006 not associated intussusception prelicensure trials, additional is important to ensure complete safety profile. METHODS. We assessed reports RotaTeq vaccination by using data Vaccine Adverse Event Reporting System and Safety...
Objective The US Vaccine Adverse Event Reporting System (VAERS) collects spontaneous reports of adverse events following vaccination. Medical officers review the and often apply standardized case definitions, such as those developed by Brighton Collaboration. Our objective was to demonstrate a multi-level text mining approach for automated classification VAERS that could potentially reduce human workload. Design We selected 6034 H1N1 vaccine were classified medical positive (Npos=237) or...
The risk of immune thrombocytopenic purpura (ITP) after childhood vaccines other than measles-mumps-rubella vaccine (MMR) is unknown.Using data from 5 managed care organizations for 2000 to 2009, we identified a cohort 1.8 million children ages 6 weeks 17 years. Potential ITP cases were by using diagnostic codes and platelet counts. All verified chart review. Incidence rate ratios calculated comparing the in (1 42 days vaccination) control periods.There 197 chart-confirmed out cohort. There...
ABSTRACT In 2009, the Department of Health and Human Services created new Post‐Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans immunization registries to monitor safety H1N1 influenza vaccine. PRISM has now been integrated into FDA's Mini‐Sentinel pilot program. It strengthens federal vaccine enterprise in two important ways. First, monitors largest US general population cohort designated for active surveillance safety....
BACKGROUND: Thrombotic events (TEs) are rare but often serious adverse that could occur after administration of immune globulin (IG) products. Our study objective was to assess occurrence recorded TEs different US‐licensed IG products and investigate potential risk factors using a large administrative database. STUDY DESIGN AND METHODS: This is retrospective claims‐based cohort individuals exposed from January 1, 2008, through September 30, 2010, HealthCore's Integrated Research Database,...
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system is a cohort-based active surveillance network initiated by the US Department of Health and Human Services to supplement preexisting other vaccine safety monitoring systems in tracking monovalent pandemic 2009 H1N1 influenza United States during 2009–2010. PRISM investigators conducted retrospective analysis determine whether vaccination was associated with increased risk any 14 prespecified outcomes. Five health insurance...
Background and Objectives Transfusion‐associated circulatory overload ( TACO ) is a serious transfusion complication resulting in respiratory distress. The study's objective was to assess occurrence potential risk factors among elderly Medicare beneficiaries (ages 65 older) the inpatient setting during 2011. Materials Methods This retrospective claims‐based study utilized administrative databases coordination with Centers for & Medicaid Services. Transfusions were identified by recorded...
Ball, R and Weidman, D. Analysis of USA Powerlifting federation data from January 1, 2012-June 11, 2016. J Strength Cond Res 32(7): 1843-1851, 2018-In this article, we report 47,913 officially judged contestant results powerlifting matches 2012 to June 2016 for the Federation. We found age sex be most complex factors in predicting results. For women, general, younger woman is more they can squat; older less squat. men with 1 exception women's squat, peak lifting power between ages 24-49, at...
Unmeasured confounding is often raised as a source of potential bias during the design nonrandomized studies, but quantifying such concerns challenging. We developed simulation-based approach to assess impact unmeasured study stage. The involved generation hypothetical individual-level cohorts using realistic parameters, including binary treatment (prevalence 25%), time-to-event outcome (incidence 5%), 13 measured covariates, confounder (u1; 10%), and "proxy" variable (p1) correlated with...