{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T20:07:37Z","timestamp":1785528457444,"version":"3.56.0"},"reference-count":52,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T00:00:00Z","timestamp":1778976000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T00:00:00Z","timestamp":1778976000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>The Problem<\/jats:title>\n                    <jats:p>Transportability considerations are increasingly important to answer research questions in comparative effectiveness research (CER) to support the transfer of evidence on medicinal products across countries or settings. As drug development costs rise and healthcare systems and professionals face economic and resource pressures, leveraging existing data and evidence generated across borders or settings can improve efficiency and inform decisions in product development and decision\u2010making (regulatory, health technology assessment [HTA] and clinical care). Differences in population characteristics, healthcare systems, and data availability, including coding discrepancies, may present significant challenges to the transportability of CER evidence. Without rigorous methodological approaches, the utility of transportability analyses is limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>What we Did<\/jats:title>\n                    <jats:p>This article provides a structured framework for considering transportability exercises in CER analyses. We outlined key methodological principles, when and why to use transportability exercises in CER, feasibility assessments including effect modifier identification and causal inference techniques such as weighting, outcome regression, and combined methods to guide transportability analytical approaches in CER. By synthesizing existing literature and expert insights, we identified opportunities and trade\u2010offs in applying transportability methods to support decisions across the product lifecycle.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Strategies to Disseminate and Facilitate Use<\/jats:title>\n                    <jats:p>To enhance the adoption of transportability analyses, we proposed best practices for researchers, regulators, HTA bodies, and industry stakeholders. These include early engagement with regulatory agencies and HTA bodies, transparent documentation of data assumptions, quality, fitness, and comparability assessments while ensuring robust analytical approaches. We also emphasized the need for standardized reporting guidelines and cross\u2010country collaborations to validate transportability methods in real\u2010world settings and communicate uncertainty in transported evidence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Transportability analyses offer a powerful tool for extending the applicability of CER findings across healthcare systems, improving evidence generation efficiency, and supporting global drug development and evaluation. By implementing best practices that promote a rigorous and transparent approach to the design and conduct of such analyses, stakeholders can maximize the value of transported treatment effects while ensuring scientific rigor and decision\u2010making relevance. Future research should focus on empirical testing and validation of transportability methods targeting different questions across the product lifecycle and the development of harmonized regulatory and HTA methodological standards. \u201cThis manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE).\u201d Official Endorsement was received on 5\/13\/26.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70396","type":"journal-article","created":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T01:04:33Z","timestamp":1779066273000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Transportability Analyses in Comparative Effectiveness Research: A Conceptual Framework and Methodological Principles Endorsed by the\n                    <scp>I<\/scp>\n                    nternational\n                    <scp>S<\/scp>\n                    ociety for\n                    <scp>P<\/scp>\n                    harmacoepidemiology"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4251-2912","authenticated-orcid":false,"given":"Blythe","family":"Adamson","sequence":"first","affiliation":[{"name":"The Comparative Health Outcomes, Policy and Economics Institute School of Pharmacy, University of Washington  Seattle Washington USA"},{"name":"Infectious Economics, LLC  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Liu","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Duffield","sequence":"additional","affiliation":[{"name":"National Institute for Health and Care Excellence  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anouk","family":"D\u00e9ruaz\u2010Luyet","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Ingelheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8387-9342","authenticated-orcid":false,"given":"Dimitri","family":"Bennett","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3825-0182","authenticated-orcid":false,"given":"Montse Soriano","family":"Gabarr\u00f3","sequence":"additional","affiliation":[{"name":"Independent Researcher  Potsdam Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehmet","family":"Burcu","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3648-8197","authenticated-orcid":false,"given":"Daniela Claudia","family":"Moga","sequence":"additional","affiliation":[{"name":"University of Kentucky  Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Welby","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2608-616X","authenticated-orcid":false,"given":"Tianze","family":"Jiao","sequence":"additional","affiliation":[{"name":"University of Florida  Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4803-7895","authenticated-orcid":false,"given":"Xuerong","family":"Wen","sequence":"additional","affiliation":[{"name":"University of Rhode Island  Kingston Rhode Island USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grammati","family":"Sarri","sequence":"additional","affiliation":[{"name":"Cytel, Inc  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4297"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5222"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1086"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m4856"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5507"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3182109296"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.8426"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1214\/14-STS486"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2007.126847"},{"key":"e_1_2_9_11_1","unstructured":"Policy DMIfH \u201cInternational Harmonization of Real World Evidence Standards Dashboard \u201d2025 accessed 16 April 16 2025 https:\/\/healthpolicy.duke.edu\/projects\/international\u2010harmonization\u2010real\u2010world\u2010evidence\u2010standards\u2010dashboard."},{"key":"e_1_2_9_12_1","unstructured":"EFPIA \u201c60 000 Fewer Clinical Trial Places for Europeans Despite Global Surge in Research Projects \u201dEuropean Federation of Pharmaceutical Industries and Associations January 1 2025."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40471-025-00374-6"},{"key":"e_1_2_9_14_1","unstructured":"FDA \u201cConsiderations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry \u201dFood and Drug Administration September 17 2025."},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2022.1073678"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.57264\/cer-2024-0064"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2025.03.001"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40273-023-01323-1"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.3389\/fepid.2024.1335241"},{"key":"e_1_2_9_20_1","unstructured":"FDA \u201cGuidance Document. 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