A5002909029- Pharmacovigilance and Adverse Drug Reactions
- Computational Drug Discovery Methods
- Statistical Methods in Clinical Trials
- Pharmaceutical Economics and Policy
- Biosimilars and Bioanalytical Methods
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical studies and practices
- Pharmaceutical Practices and Patient Outcomes
- Biomedical Text Mining and Ontologies
- Academic integrity and plagiarism
- Drug-Induced Adverse Reactions
- Mathematical and Theoretical Epidemiology and Ecology Models
- Semantic Web and Ontologies
- Meta-analysis and systematic reviews
- Machine Learning in Healthcare
- Schizophrenia research and treatment
- Pharmacogenetics and Drug Metabolism
- Data-Driven Disease Surveillance
- Advanced Database Systems and Queries
- Evolution and Genetic Dynamics
- Natural Language Processing Techniques
- Drug-Induced Hepatotoxicity and Protection
- Animal Ecology and Behavior Studies
- Analytical Methods in Pharmaceuticals
- Data Quality and Management
London School of Hygiene & Tropical Medicine
2021-2025
University of London
2021-2024
New York University
2012-2024
GlaxoSmithKline (United Kingdom)
2020-2024
Utrecht University
2024
Middlesex University
2022
University of York
2016-2021
Dorking Community Hospital
2020
Pfizer (United States)
2009-2019
Pfizer (United Kingdom)
2014-2019
Abstract Purpose A continuous systematic review of all combinations drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary optimize signal detection. To focus attention human reviewers, quantitative procedures can be used sift data in different ways. In various centres, measures are quantify the extent which an ADR disproportionally certain drug compared generality database. The objective this study examine level concordance estimates measure by...
Large observational data sets are a great asset to better understand the effects of medicines in clinical practice and, ultimately, improve patient care. For an empirical pattern be practical relevance, it should represent substantial deviation from null model. purpose identifying such deviations, statistical significance tests inadequate, as they do not on their own distinguish magnitude effect its support. The observed-to-expected (OE) ratio other hand directly measures strength...
In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect signals. Unfortunately, publishing lacks specific guidelines, often leading incomplete and ambiguous reporting, carries the risk of incorrect conclusions when data not placed in correct context. The REporting A Disproportionality analysis for drUg Safety signal detection using PharmacoVigilance (READUS-PV) statement was developed address this issue by promoting transparent...
Studies that generate real-world evidence on the effects of medical products through analysis digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers. Ensuring reproducibility such findings is fundamental to effective evidence-based decision-making. We reproduce results 150 studies published peer-reviewed journals using same databases as original investigators evaluate completeness reporting 250. Original reproduction...
Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their and results generally poorly reported published articles existing guidelines do not capture specific features disproportionality analyses. We here describe development a guideline (REporting A analysis drUg Safety signal detection individual case PharmacoVigilance [READUS-PV]) reporting abstracts....
Post-marketing drug safety data sets are often massive, and entail problems with heterogeneity selection bias. Nevertheless, quantitative methods have proven a very useful aid to help clinical experts in screening for previously unknown associations these sets. The WHO international database is the world's largest set of its kind over three million reports on suspected adverse reaction incidents. Since 1998, an exploratory analysis method has been routine use screen this set. This was...
Interaction between drug substances may yield excessive risk of adverse reactions (ADRs) when two drugs are taken in combination. Collections individual case safety reports (ICSRs) related to suspected ADR incidents clinical practice have proven be very useful post-marketing surveillance for pairwise drug--ADR associations, but yet reach their full potential drug-drug interaction surveillance. In this paper, we implement and evaluate a shrinkage observed-to-expected ratio exploratory...
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes Therapeutics by European ConsorTium) project has addressed key research questions relevant to science safety signal detection. The results studies conducted into quantitative detection in spontaneous reporting, clinical trial and electronic health records databases are summarised 39 recommendations have been formulated, many based comparative analyses across range (e.g....
This paper describes a vision-based obstacle detection and navigation system for use as part of robotic solution the sustainable intensification broad-acre agriculture. To be cost-effective, robotics must competitive with current human-driven farm machinery. Significant costs are in high-end localization sensors. Our demonstrates combination an inexpensive global positioning inertial vision single stereo detection. The design robot, including detailed descriptions three key parts system:...
Data mining disproportionality methods (PRR, ROR, EBGM, IC, etc.) are commonly used to identify drug safety signals in spontaneous report system (SRS) databases. Newer data sources such as longitudinal observational databases (LOD) provide time-stamped patient-level information and overcome some of the SRS limitations an absence denominator, total number patients who consume a drug, limited temporal information. Application LODs has not been widely explored. The scale LOD provides...
Studies on drug utilization usually do not allow direct cross-national comparisons because of differences in the respective applied methods. This study aimed to compare time trends BZDs prescribing by applying a common protocol and analyses plan seven European electronic healthcare databases.Crude standardized prevalence rates from 2001-2009 were calculated databases Spain, United Kingdon (UK), The Netherlands, Germany Denmark. Prevalence was stratified age, sex, BZD type [(using ATC codes),...
This database study compares surveillance data on immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors to determine whether irAEs experienced during anti–PD-1 therapy correlate tumor mutational burden across 18 cancer types.