Integrating real-world evidence in the regulatory decision-making process: a systematic analysis of experiences in the US, EU, and China using a logic model

M Li, S Chen, Y Lai, Z Liang, J Wang, J Shi… - Frontiers in …, 2021 - frontiersin.org
Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing
attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the …

Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain

MA Maciá‐Martínez, M Gil, C Huerta… - … and Drug Safety, 2020 - Wiley Online Library
Abstract Purpose Base de Datos para la Investigación Farmacoepidemiológica en Atención
Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish …

Incidence rates of autoimmune diseases in European healthcare databases: A contribution of the ADVANCE project

C Willame, C Dodd, L van der Aa, G Picelli, HD Emborg… - Drug Safety, 2021 - Springer
Introduction The public–private ADVANCE collaboration developed and tested a system to
generate evidence on vaccine benefits and risks using European electronic healthcare …

Validation of Administrative Data and Timing of Point Prevalence Surveys for Antibiotic Monitoring

R Boracchini, G Brigadoi, E Barbieri… - JAMA Network …, 2024 - jamanetwork.com
Importance Point prevalence surveys (PPSs) are used globally to collect data on antibiotic
prescriptions. However, the optimal frequency for data collection to ensure comprehensive …

Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review

R Gini, R Pajouheshnia, H Gardarsdottir… - … and drug safety, 2024 - Wiley Online Library
Purpose Real‐world evidence (RWE) is increasingly used for medical regulatory decisions,
yet concerns persist regarding its reproducibility and hence validity. This study addresses …

Fit for purpose assessment: a new direction for IACUCs

LB Kinter, DK Johnson, RH Weichbrod… - ILAR …, 2021 - academic.oup.com
The organization and function of the institutional animal care and use committee (IACUC) is
the key component of government regulation and oversight of necessary scientific research …

Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance

P Imbrici, M De Bellis, A Liantonio… - … Toxicology: Methods and …, 2024 - Springer
Rapid and detailed post-marketing surveillance of drugs and vaccine is required to enable
assessment of their real-world safety and effectiveness. Spontaneous reporting from …

[HTML][HTML] ADVANCE: Towards near real-time monitoring of vaccination coverage, benefits and risks using European electronic health record databases

K Bollaerts, T De Smedt, C McGee, HD Emborg, M Villa… - Vaccine, 2020 - Elsevier
Abstract Background The Accelerated Development of VAccine beNefit-risk Collaboration in
Europe (ADVANCE) is a public-private partnership aiming to develop and test a system for …

Vascular and metabolic risk factor differences prior to dementia diagnosis: a multidatabase case–control study using European electronic health records

G Perera, PR Rijnbeek, M Alexander, D Ansell… - BMJ open, 2020 - bmjopen.bmj.com
Objective The objective of the study is to compare body mass index (BMI), systolic/diastolic
blood pressure (SBP/DBP) and serum total cholesterol levels between dementia cases and …

[HTML][HTML] Quantifying outcome misclassification in multi-database studies: the case study of pertussis in the ADVANCE project

R Gini, CN Dodd, K Bollaerts, C Bartolini, G Roberto… - Vaccine, 2020 - Elsevier
Abstract Background The Accelerated Development of VAccine beNefit-risk Collaboration in
Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for …