Launched in 2022, the Core Concepts in Pharmacoepidemiology is a section of Pharmacoepidemiology and Drug Safety (PDS) that contains a series of review articles on a curated list of methodological topics that are highly relevant to our field. These articles are written to provide a broad overview on a given topic at a level that would make them well suited to explain these concepts in a grant application or when teaching these concepts to pharmacoepidemiology trainees. The use of a rigorous selection process (described below) ensures that they are written by experts in the area. There have been two prior rounds of Core Concepts in Pharmacoepidemiology published to date, each including seven manuscripts (Table 1).
TABLE 1.
Articles published in Pharmacoepidemiology and Drug Safety's Core Concepts in Pharmacoepidemiology section.
| Article | Year | Multi‐institutional collaboration | Citations* |
|---|---|---|---|
| Round 1 | |||
| Core Concepts in Pharmacoepidemiology: Violations of the Positivity Assumption in the Causal Analysis of Observational Data: Consequences and Statistical Approaches [1] | 2021 | Yes | 61 |
| Core Concepts in Pharmacoepidemiology: Fundamentals of the Cohort and Case‐Control Study Designs [2] | 2022 | No | 13 |
| Core Concepts in Pharmacoepidemiology: Key Biases Arising in Pharmacoepidemiologic Studies [3] | 2023 | No | 58 |
| Core Concepts in Pharmacoepidemiology: Confounding by Indication and the Role of Active Comparators [4] | 2022 | No | 129 |
| Core Concepts in Pharmacoepidemiology: Measures of Drug Utilization Based on Individual‐Level Drug Dispensing Data [5] | 2022 | Yes | 61 |
| Core Concepts in Pharmacoepidemiology: Validation of Health Outcomes of Interest Within Real‐World Healthcare Databases [6] | 2023 | Yes | 38 |
| Core Concepts in Pharmacoepidemiology: Measurement of Medication Exposure in Routinely Collected Healthcare Data for Causal Inference Studies in Pharmacoepidemiology [7] | 2024 | No | 5 |
| Round 2 | |||
| Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis in Pharmacoepidemiology [8] | 2024 | Yes | 2 |
| Core Concepts in Pharmacoepidemiology: New‐User Designs [9] | 2024 | Yes | 19 |
| Core Concepts in Pharmacoepidemiology: Principled Use of Artificial Intelligence and Machine Learning in Pharmacoepidemiology and Healthcare Research [10] | 2024 | No | 1 |
| Core Concepts in Pharmacoepidemiology: Time‐to‐Event Analysis Approaches in Pharmacoepidemiology [11] | 2024 | No | 3 |
| Core Concepts: Self‐Controlled Designs in Pharmacoepidemiology [12] | 2025 | Yes | 10 |
| Core Concepts in Pharmacoepidemiology: Multi‐Database Distributed Data Networks [13] | 2025 | Yes | 5 |
| Evaluation of Drug‐Drug Interactions in Pharmacoepidemiologic Research [14] | 2025 | Yes | 11 |
According to Scopus on May 18, 2026.
Although it is early to definitively assess article performance, particularly for those published in the second round, a preliminary assessment of the articles bibliometrics suggests that they have been impactful. Compared with other publication types published in PDS between 2001 and 2025, the Core Concepts in Pharmacoepidemiology manuscripts have had a substantially higher mean number of total downloads (4041 vs. 1303) and mean number of citations (29.8 vs. 5.2). Furthermore, while there were only 14 Core Concepts in Pharmacoepidemiology publications out of the 868 total publications during this period, four of them are ranked in the 10 most cited PDS papers published during this time period (Personal Communication, Michael Xu, Associate Publisher, Wiley).
The process used to develop and solicit the Core Concepts in Pharmacoepidemiology topics and writing groups has evolved greatly during the first two rounds [15]. In round 1, the Core Concepts Section Editors consulted the Editor‐in‐Chief, Regional Editors, and Associate Editors of PDS, as well as the International Society for Pharmacoepidemiology (ISPE) Publications and Communications Committee to develop the list of topics and then sent targeted invitations to institutions with pharmacoepidemiologic training programs to secure writing groups. Importantly, all writing groups had to include a trainee or recent graduate as a co‐author. While this process was successful in developing a robust series of review articles with relevance to those early in their careers, authorship was restricted to academics predominantly from North America (Table 1). A revised process was used for round 2 in which the Section Editors developed an initial topic list, with this list subsequently reviewed and augmented by the leadership of the ISPE Publications and Communications Committee and the PDS Associate Editors of the Americas Office. The list was then shared with the Editor‐in‐Chief and the remaining Regional Editors of PDS. Finally, a Call for Writing Teams was published in PDS [15]. This revised process resulted in greater engagement across the ISPE membership and broadened inclusion of nonacademic writing groups (Table 1).
We are now excited to solicit applications from potential writing groups for round 3 of the Core Concepts in Pharmacoepidemiology section. The topics selected for the third round of the section are described in the Box 1. These topics were selected using a similar process as for round 2. Interested groups should submit their letter of intent to us via email (kristian.filion@mcgill.ca and jennifer.lund@unc.edu) and include their topic of interest, the composition of their writing group (including name, position, and institution), and their relevant expertise. Consistent with earlier rounds, the proposed lead author of the Core Concept in Pharmacoepidemiology article should be a trainee (defined as no more than 3 years beyond completion of their terminal degree). Priority will be given to writing groups with an international composition. In the event that more than one writing group expresses interest in a given topic, we may contact interested groups to explore the possibility of working together. Although we are not accepting applications for topics not listed in the Box 1 for this round, we welcome suggestions for topics for future iterations of this section of PDS. The deadline to submit letters of intent is October 1st, 2026.
BOX 1. Topics selected for the third round of Pharmacoepidemiology and Drug Safety's Core Concepts in Pharmacoepidemiology section.
Use and implementation of propensity score methods
Controlled interrupted time series analysis
Methods for handling missing data in electronic healthcare data
Methods for evaluating subgroup effects
Methods for identifying trajectories of medication adherence
Benefit‐risk assessment
Approaches to address unmeasured confounding
Pharmacology for pharmacoepidemiologists
With real‐world evidence playing an increasing role in clinical and regulatory decision‐making [16, 17, 18] and the ever‐increasing volume of the medical literature [19], it is essential that pharmacoepidemiologists, trainees, and other consumers of the pharmacoepidemiologic literature have a trusted source for high‐quality reviews of key methodological concepts. We look forward to working with potential writing groups in this next round of the Core Concepts in Pharmacoepidemiology series to continue to meet this need of the pharmacoepidemiologic community.
Author Contributions
K.B.F. drafted the manuscript. J.L.L. revised the manuscript for important intellectual content. Both authors approved the final version for submission.
Funding
The authors have nothing to report.
Conflicts of Interest
K.B.F. has received personal fees from Statlog and Regeneron, all outside the current work. K.B.F. and J.L.L. are Associate Editors and Co‐Section‐Editors of the Core Concepts in Pharmacoepidemiology Section of PDS and co‐authored this article. They were excluded from editorial decision‐making related to the acceptance of this article for publication in the journal.
Acknowledgments
K.B.F. is supported by a Merit salary support award from the Fonds de recherche du Québec—santé and a William Dawson Scholar award from McGill University. We thank the editors at PDS and the ISPE Publications and Communications Committee for their valuable contributions to topic selection.
Data Availability Statement
Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.
