Correction: Leveraging real-world data for safety signal detection and risk management in pre-and post-market settings

Kathleen M Gavin^1*Matthew L Sundermann²Alethea Wieland²

• ¹Datavant Inc, Phoenix, United States
• ²Advarra Inc, Columbia, United States

A correction refers to a change to their article that the author wishes to publish after publication. The publication of this article is subject to Frontiers' editorial approval.Instructions:• Please read through all the templates before choosing • Pick the most relevant text template(s) from the following page and delete all others.• Edit the text as necessary, ensuring that the original incorrect text is included for the record, please see the below. • Please do not use any extra formatting when editing the templates, and only modify the red text unless absolutely necessary • Submit to Frontiers following the instructions on this page.When the original text contained incorrect information, to preserve the scientific record, please include that text when editing the below templates. For example:There was a mistake in the Funding statement, an incorrect number was used.The correct number is "2015C03Bd051.". The publisher apologizes for this mistake.The original version of this article has been updated. The reference for [EMA, 2017] was erroneously written as EMA (2017). Guideline on good pharmacovigilance practices (GVP) module IX -Signal management. Available online at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf. It should be [European Medicines Agency (2017). Guideline on good pharmacovigilance practices (GVP) module IX -Signal management. Available online at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf].The reference for [European Medicines Society, 2023] was erroneously written as [European Medicines Society (2023). ICH M14 general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines -scientific guideline. Available online at: https://www.ema.europa.eu/en/ich-m14-guideline-general-principles-plan-design-analysis-pharmacoepidemiological-studies-utilize-real-world-data-safety-assessment-medicines-scientificguideline.]. It should be [European Medicines Agency (2025). ICH M14 general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines -scientific guideline. Available online at: https://www.ema.europa.eu/en/ich-m14-guideline-general-principles-plan-design-analysis-pharmacoepidemiological-studies-utilize-real-world-data-safetyassessment-medicines-scientific-guideline].The reference for [European Medicines Society, 2025] was erroneously written as [European Medicines Society (2025). Data analysis and real world interrogation network (DARWIN EU). Available online at: https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu]. It should be [European Medicines Agency (2025). Data analysis and real world interrogation network (DARWIN EU). Available online at: https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu].The reference for [Rosati et al., 2022] was erroneously written as [Rosati, K., Jorgensen, N., Soliz, M., and Evans, B. (2022). HIPAA and common rule compliance in the Sentinel initiative. Sentinel initiative principles and policies.]. It should be [Rosati, K., Jorgensen, N., Soliz, M., and Evans, B. (2018). HIPAA and common rule compliance in the Sentinel initiative. Sentinel initiative principles and policies. Available at: https://www.sentinelinitiative.org/sites/default/files/communications/publications-presentations/HIPAA-Common-Rule-Compliance-in-Sentinel-Initiative.pdf].The reference for [U.S. Food and Drug Administration, 2023a] was erroneously written as [U.S. Food and Drug Administration (2023a). Data standards for drug and biological product submissions containing real-world data guidance document. Available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-worldevidence-support-regulatory-decision-making-drug.]. It should be [U.S. Food and Drug Administration (2023a). Data standards for drug and biological product submissions containing real-world data guidance document. Available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data]. for a reason not seen here, please contact the journal's editorial office.