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Review
. 2025 Jul;34(7):e70175.
doi: 10.1002/pds.70175.

Advancing Health Equity in Europe: Explore, Tailor, Implement, and Evaluate (ETIE)-A Framework of Diversity and Fairness in Pharmacoepidemiologic Research

Enriqueta Vallejo-Yagüe  1 , Sieta T de Vries  2 , Daniel La Parra-Casado  3 , Helga Gardarsdottir  4   5   6 , Maria Luisa Faquetti  7 , Irene van Valkengoed  8 , Elodie Aubrun  9 , Antonios Douros  10 , Sandra Guedes  11 , Adrian Martinez-De La Torre  7   12   13 , Jakob Wested  14   15 , Taichi Ochi  16   17 , Anne Marie Schumacher Dimech  13 , Carole Clair  18 , Isha Mehta  19 , Fidelia Ida  20 , Montse Soriano Gabarró  21 , Oleksii Korzh  22 , María Martínez-González  23   24 , Ariadna Maso  25 , Diana Clamote Rodrigues  26 , Jackie R Ndem-Galbert  27   28 , Marta Korjagina  29 , Swarnali Goswami  30 , Daniela C Moga  31   32 , Andrea Fleisch Marcus  19 , Hedvig Nordeng  33   34
Affiliations
Free article
Review

Advancing Health Equity in Europe: Explore, Tailor, Implement, and Evaluate (ETIE)-A Framework of Diversity and Fairness in Pharmacoepidemiologic Research

Enriqueta Vallejo-Yagüe et al. Pharmacoepidemiol Drug Saf. 2025 Jul.
Free article

Abstract

Pharmacoepidemiology should represent and benefit populations equitably, embracing diversity and equity, and ensuring fairness. This article describes equity and fairness in pharmacoepidemiology, depicts key diversity domains, and provides an operational framework and call for action to implement diversity and fairness in pharmacoepidemiologic research. To ensure fairness, studies should address diversity and inclusion while providing equal opportunities and benefits for everyone in the target population. To implement and evaluate fairness in pharmacoepidemiology, we defined the following diversity domains: biological sex, socially constructed gender, age, life stages (e.g., pregnancy, menopause), ethnicity, race, migration, nationality, socioeconomic status, education, health literacy, and health status and capabilities. These are determinants of health, either through biological pathways or through social norms, discrimination, and barriers to healthcare or research participation. They are interlinked, their impact is study- and context-specific, and due to their sensitive and evolving nature, they should be handled with caution. Implementing diversity domains enables researchers to assess the generalizability of findings, identify and address health inequities, account for determinants of health, and ensure the fairness of algorithms, implementations, and recommendations. To successfully implement diversity domains and ensure fair pharmacoepidemiologic research, we recommend researchers to follow the Explore, Tailor, Implement, and Evaluate (ETIE) framework: Explore the role/implication of the diversity domains in the study, tailor their definitions to the study context, implement them appropriately and evaluate the study findings in their context. Increased availability of diversity data is needed, and support from stakeholders is essential. This manuscript was endorsed by the International Society for Pharmacoepidemiology (ISPE).

Keywords: diversity; fairness; health equity; inclusion; pharmacoepidemiology.

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References

    1. C. Pasin, C. R. Consiglio, J. S. Huisman, et al., “Sex and Gender in Infection and Immunity: Addressing the Bottlenecks From Basic Science to Public Health and Clinical Applications,” Royal Society Open Science 10, no. 7 (2023): 221628, https://doi.org/10.1098/rsos.221628.
    1. History of Women's Participation in Clinical Research, “Office of Research on Women's Health,” 2023, https://orwh.od.nih.gov/toolkit/recruitment/history.
    1. C. Heller, J. E. Balls‐Berry, J. D. Nery, et al., “Strategies Addressing Barriers to Clinical Trial Enrollment of Underrepresented Populations: A Systematic Review,” Contemporary Clinical Trials 39, no. 2 (2014): 169–182, https://doi.org/10.1016/j.cct.2014.08.004.
    1. M. Coakley, E. O. Fadiran, L. J. Parrish, R. A. Griffith, E. Weiss, and C. Carter, “Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials,” Journal of Women's Health 21, no. 7 (2012): 713–716, https://doi.org/10.1089/jwh.2012.3733.
    1. FDA News Release, FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials, ed. FDA (U.S. Food and Drug Administration, 2022). file:///C:/Users/ev23q867/Zotero/storage/F89D6U29/fda‐takes‐important‐steps‐increase‐racial‐and‐ethnic‐diversity‐clinical‐trials.html.