{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:30:38Z","timestamp":1786591838522,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma US","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Many factors contribute to developing and conducting a successful multi\u2010data source, non\u2010interventional, post\u2010authorization safety study (NI\u2010PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post\u2010marketing requirement (PMR)\/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We provide context and share learnings, including sections on research program collaboration, scientific transparency, organizational approach, mitigation of uncertainty around potential delays, validity of study outcomes, selection of data sources and optimizing patient numbers, choice of comparator groups and enhancing precision of estimates of associations, potential confounding and generalizability of study findings, and interpretation of results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This large PMR\/PASS program was a long\u2010term commitment from all parties and benefited from an effective coordinating center and extensive scientific interactions across research partners, scientific advisory board, study sponsor, and health authorities, and delivered useful learnings related to the design and organization of multi\u2010data source NI\u2010PASS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5799","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T03:40:48Z","timestamp":1714362048000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Lessons learned from a multi\u2010data source research collaboration: The mirabegron post\u2010authorization safety study program"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7318-2288","authenticated-orcid":false,"given":"Stefan","family":"de Vogel","sequence":"first","affiliation":[{"name":"Pharmacovigilance Astellas Pharma B.V.  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8020-3144","authenticated-orcid":false,"given":"John D.","family":"Seeger","sequence":"additional","affiliation":[{"name":"Epidemiology Optum  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1593-3124","authenticated-orcid":false,"given":"Alejandro","family":"Arana","sequence":"additional","affiliation":[{"name":"Epidemiology RTI Health Solutions  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7388-6082","authenticated-orcid":false,"given":"Andrea V.","family":"Margulis","sequence":"additional","affiliation":[{"name":"Epidemiology RTI Health Solutions  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa J.","family":"McQuay","sequence":"additional","affiliation":[{"name":"Epidemiology RTI Health Solutions, Research Triangle Park  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5798-3691","authenticated-orcid":false,"given":"Susana","family":"Perez\u2010Gutthann","sequence":"additional","affiliation":[{"name":"Epidemiology RTI Health Solutions  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8097-8708","authenticated-orcid":false,"given":"Jesper","family":"Hallas","sequence":"additional","affiliation":[{"name":"Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina Sahlertz","family":"Kristiansen","sequence":"additional","affiliation":[{"name":"Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2619-2189","authenticated-orcid":false,"given":"Marie","family":"Linder","sequence":"additional","affiliation":[{"name":"Medicine, Centre for Pharmacoepidemiology Karolinska Institutet  Solna Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingvild","family":"Odsbu","sequence":"additional","affiliation":[{"name":"Medicine, Centre for Pharmacoepidemiology Karolinska Institutet  Solna Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon","family":"Suehs","sequence":"additional","affiliation":[{"name":"Health Economics and Outcomes Research Humana Healthcare Research  Louisville Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yihua","family":"Xu","sequence":"additional","affiliation":[{"name":"Health Economics and Outcomes Research Humana Healthcare Research  Louisville Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Uribe","sequence":"additional","affiliation":[{"name":"Health Economics and Outcomes Research Humana Healthcare Research  Louisville Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwame","family":"Appenteng","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Astellas Pharma US  Northbrook Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah Jamie","family":"Robinson","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Astellas Pharma B.V.  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,29]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"International Continence Society (ICS).https:\/\/www.ics.org\/committees\/standardisation\/terminologydiscussions\/overactivebladder. Accessed June 2023"},{"key":"e_1_2_9_3_1","unstructured":"U.S. Food and Drug Administration (FDA).https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2012\/202611Orig1s000TOC.cfm. Accessed June 2023"},{"key":"e_1_2_9_4_1","unstructured":"European Medicines Agency (EMA).https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/betmiga. Accessed June 2023"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-021-01095-7"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2021.1891035"},{"key":"e_1_2_9_7_1","first-page":"617","volume-title":"Pharmacoepidemiology","author":"Toh S","year":"2020"},{"key":"e_1_2_9_8_1","volume-title":"Mini\u2010Sentinel Prospective Surveillance Plan: Prospective Routine Observational Monitoring of Mirabegron","author":"Leonard CE","year":"2016"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-017-0124-7"},{"key":"e_1_2_9_10_1","unstructured":"EU PAS register.https:\/\/www.encepp.eu\/encepp\/studiesDatabase.jsp. 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