Frontiers in Drug Safety and Regulation | Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Opinion

Published on 16 Sep 2025

Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Priyanka Chhikara
Tarek A. Hammad

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1678074

1,092 views

Original Research

Published on 10 Sep 2025

Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

M. F. Almas
A. Girardi
S. Crisafulli
K. Gvozdanovic
K. M. Hakkarainen
G. Hyeraci
W. E. Hoogendoorn
B. Rillmann
G. Roberto
G. Vitturi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1574430

1,162 views

Perspective

Accepted on 02 Sep 2025

Leveraging Real-World Data for Safety Signal Detection and Risk Management in Pre-and Post-Market Settings

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kathleen M Gavin
Matthew L Sundermann
Alethea Wieland

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1626822

513 views

Mini Review

Accepted on 25 Aug 2025

Tokenization Techniques for Privacy-Preserving Healthcare Data: Tokenization Nuts and Bolts

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Camille Cook

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1599217

528 views

Review

Published on 20 Jun 2025

Centralized daily drug management in clinical trial institutions and specific implementation plans

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Yu Tang
Xiaolong Fang

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1620314

1,264 views

Editorial

Published on 11 Mar 2025

Editorial: External control arms for single-arm studies: methodological considerations and applications

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

1,722 views

Perspective

Published on 13 Feb 2025

Implementing tokenization in clinical research to expand real-world insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Chelsea Walters
Crystal S. Langlais
Eva E. Oakkar
Wilhelmina E. Hoogendoorn
James B. Coutcher
Mui Van Zandt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1519307

3,346 views

Review

Published on 18 Dec 2024

Important tool in our rare disease toolbox: hybrid retrospective-prospective natural history studies serve well as external comparators for rare disease studies

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Chinenye Ugoji
Julien Heidt
Joan Largent
Emily Bratton
Laura Hester
Sareh Keshavarzi
Stuart Turner
Christina Mack

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1418050

2,538 views

Original Research

Published on 06 Dec 2024

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

1,501 views

Mini Review

Published on 13 Nov 2024

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Julie V. Kim
Sharon E. Davis
Michael E. Matheny
Joshua C. Smith

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

2,391 views
2 citations

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

2,360 views
2 citations

Perspective

Published on 30 Oct 2024

External comparator studies and the joint application of the estimand and target trial emulation frameworks

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

2,091 views
1 citation

Opinion

Published on 18 Sep 2024

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

2,366 views
1 citation

Original Research

Published on 16 Aug 2024

Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Simon Davis
Salman Afsar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445998

2,599 views
3 citations

Original Research

Published on 19 Jul 2024

Measurement error and bias in real-world oncology endpoints when constructing external control arms

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Benjamin Ackerman
Ryan W. Gan
Craig S. Meyer
Jocelyn R. Wang
Youyi Zhang
Jennifer Hayden
Grace Mahoney
Jennifer L. Lund
Janick Weberpals
Sebastian Schneeweiss

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1423493

4,648 views
1 citation

Original Research

Published on 27 Jun 2024

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Dan Li
Leihong Wu
Mingfeng Zhang
Svitlana Shpyleva
Ying-Chi Lin
Ho-Yin Huang
Ting Li
Joshua Xu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1379260

4,183 views
5 citations