{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:56:23Z","timestamp":1791276983716,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005565","name":"Johnson & Johnson Innovative Medicine","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005565","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":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To summarize experience with Johnson &amp; Johnson's novel Active Safety Surveillance Using Real\u2010world Evidence (ASSURE) program for producing efficient, transparent, applicable, and impactful RWE to support routine pharmacovigilance processes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ASSURE follows a stepwise framework that encompasses database diagnostics to assess fit\u2010for\u2010purpose real\u2010world data (RWD) sources in the US, France, Germany, Australia, and Japan, phenotype development, query specification, and analytic implementation, objective study validity diagnostics, and standardized reporting. Licensed RWD sources are transformed into the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), from which we generate evidence for safety signal evaluation questions using a suite of open\u2010source analytic tools made publicly available through the OHDSI community. For each signal evaluation request involving a medication exposure and outcome(s), we conducted population characterization and population\u2010level causal effects estimation. Target medication, comparator medication, and indication cohorts utilize predefined phenotypes, when available, for rapid analytics. We provide an evaluation of the initial implementation of this framework, including results from database diagnostics, phenotype development, and objective study validity diagnostics applied prior to unblinding evidence to prevent exposing biased estimates. We defined efficiency as the time from query to results and integration of results into safety decisions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The initial 19\u2009months of the ASSURE program supported 110 safety signal evaluations across 24 unique products that arose from 47 requests. 74 evaluations (67%) passed study diagnostics and yielded effect estimation results with 62 (54%) providing propensity\u2010score adjusted comparative cohort method results and 40 (36%) providing self\u2010controlled case series results. Many analyses failed one or more diagnostics, preventing the generation and unblinding of potentially biased results: database (7 evaluations), phenotype specification (3 evaluations), or the requisite objective study validity diagnostics (26 evaluations). These 26 evaluations (24%) all provided population characterizations of exposure, indication, and outcome, including incidence rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The ASSURE framework and implementation process, in collaboration with safety management teams, enables rapid response to medical product safety signals under evaluation and produces actionable RWE that supports pharmacovigilance decision making within regulatory timeframes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70435","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T08:09:13Z","timestamp":1784880553000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Active Safety Surveillance Using Real\u2010World Evidence (ASSURE) Implementation: Transparent and Reproducible Real\u2010World Evidence Standardized Framework to Support Safety Signal Evaluation"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7087-9159","authenticated-orcid":false,"given":"Kevin","family":"Haynes","sequence":"first","affiliation":[{"name":"Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenna","family":"Reps","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2682-2187","authenticated-orcid":false,"given":"Jill","family":"Hardin","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7401-8877","authenticated-orcid":false,"given":"Eva\u2010Maria","family":"Didden","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Gilbert","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Swerdel","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Bohn","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell M.","family":"Conover","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  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&amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Ryan","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martijn","family":"Schuemie","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1426"},{"key":"e_1_2_11_3_1","unstructured":"\u201cFramework for FDA's Real\u2010world Evidence Program \u201d(2018) accessed September 9 2025 https:\/\/www.fda.gov\/media\/120060\/download."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5820"},{"key":"e_1_2_11_5_1","unstructured":"\u201cData Analysis and Real World Interrogation Network (DARWIN EU) 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