{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T13:52:33Z","timestamp":1767707553413,"version":"3.37.3"},"reference-count":74,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,10,25]],"date-time":"2018-10-25T00:00:00Z","timestamp":1540425600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceutical Statistics"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:p>Networks of constellations of longitudinal observational databases, often electronic medical records or transactional insurance claims or both, are increasingly being used for studying the effects of medicinal products in real\u2010world use. Such databases are frequently configured as distributed networks. That is, patient\u2010level data are kept behind firewalls and not communicated outside of the data vendor other than in aggregate form. Instead, data are standardized across the network, and queries of the network are executed locally by data partners, and summary results provided to a central research partner(s) for amalgamation, aggregation, and summarization. Such networks can be huge covering years of data on upwards of 100 million patients. Examples of such networks include the FDA Sentinel Network, ASPEN, CNODES, and EU\u2010ADR. As this is a new emerging field, we note in this paper the conceptual similarities and differences between the analysis of distributed networks and the now well\u2010established field of meta\u2010analysis of randomized clinical trials (RCTs). We recommend, wherever appropriate, to apply learnings from meta\u2010analysis to help guide the development of distributed network analyses of longitudinal observational databases.<\/jats:p>","DOI":"10.1002\/pst.1908","type":"journal-article","created":{"date-parts":[[2018,10,26]],"date-time":"2018-10-26T02:13:24Z","timestamp":1540520004000},"page":"65-77","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Lessons from meta\u2010analyses of randomized clinical trials for analysis of distributed networks of observational databases"],"prefix":"10.1002","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3151-3653","authenticated-orcid":false,"given":"Andrew","family":"Bate","sequence":"first","affiliation":[{"name":"Pfizer  Tadworth UK"},{"name":"New York University  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christy","family":"Chuang\u2010Stein","sequence":"additional","affiliation":[{"name":"Chuang\u2010Stein Consulting LLC  Kalamazoo MI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7378-7615","authenticated-orcid":false,"given":"Andrew","family":"Roddam","sequence":"additional","affiliation":[{"name":"GSK  West Drayton UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Byron","family":"Jones","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,10,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2015.12.002"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4004"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3828"},{"issue":"1","key":"e_1_2_8_5_1","first-page":"S352","article-title":"Review of epidemiology studies using multiple healthcare databases","volume":"20","author":"Cai B","year":"2011","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-017-0592-4"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyv098"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781119959946.ch13"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.2188\/jea.JE20090066"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-015-0297-5"},{"issue":"1","key":"e_1_2_8_11_1","first-page":"1189","article-title":"Data extraction and management in networks of observational health care databases for scientific research: a comparison of EU\u2010ADR, OMOP, Mini\u2010Sentinel and MATRICE strategies","volume":"4","author":"Gini R","year":"2016","journal-title":"EGEMS (Wash DC)"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-153-9-201011020-00010"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2053"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-1722H"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.607"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp0905338"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2336"},{"issue":"1","key":"e_1_2_8_18_1","first-page":"1","article-title":"The U.S. Food and Drug Administration's Mini\u2010Sentinel program: status and direction","volume":"21","author":"Platt R","year":"2012","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2242"},{"key":"e_1_2_8_20_1","unstructured":"IMEDS.Innovation in Medical Evidence Development and Surveillance.2018[cited 2018 31st August 2018]. imeds.reaganudall.org"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4392"},{"issue":"3","key":"e_1_2_8_22_1","first-page":"S6","article-title":"Risk minimization evaluation in a distributed data network\u2010An IMEDS evaluation pilot assessment of the 2010 class label change for proton pump inhibitors","volume":"25","author":"Sobel RE","year":"2016","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"3","key":"e_1_2_8_23_1","first-page":"S531","article-title":"Oral contraceptives and VTE across the Sentinel data network\u2014an IMEDS evaluation pilot assessment","volume":"25","author":"Bate A","year":"2016","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3181d9919f"},{"issue":"3","key":"e_1_2_8_25_1","first-page":"204","article-title":"The Patient\u2010Centered Outcomes Research Network: a national infrastructure for comparative effectiveness research","volume":"75","author":"Califf RM","year":"2014","journal-title":"N C Med J"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1136\/amiajnl-2014-002747"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2014.0121"},{"key":"e_1_2_8_28_1","first-page":"574","article-title":"Observational Health Data Sciences and Informatics (OHDSI): opportunities for observational researchers","volume":"216","author":"Hripcsak G","year":"2015","journal-title":"Stud Health Technol Inform"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3439"},{"issue":"4","key":"e_1_2_8_30_1","first-page":"e134","article-title":"CNODES: The Canadian network for observational drug effect studies","volume":"6","author":"Suissa S","year":"2012","journal-title":"Open Medicine"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1197\/jamia.M3191"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.2174\/1574884708666131111211802"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3281"},{"key":"e_1_2_8_34_1","unstructured":"How ARIA Analyses Have Been Used by FDA.2018; Available from:https:\/\/www.sentinelinitiative.org\/drugs\/how\u2010aria\u2010analyses\u2010have\u2010been\u2010used\u2010fda."},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/s15010-015-0768-8"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3440"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2013-304738"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/2013.jamainternmed.34"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00223-014-9850-y"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.155.3.354"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200528110-00002"},{"volume-title":"Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII","year":"2010","author":"Council for International Organozations of Medical Sciences (COIMS)","key":"e_1_2_8_42_1"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2007.08.012"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4295"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4305"},{"key":"e_1_2_8_46_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1082"},{"key":"e_1_2_8_47_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2229"},{"key":"e_1_2_8_48_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2009.00600.x"},{"key":"e_1_2_8_49_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4297"},{"volume-title":"Evidence Synthesis and Meta\u2010Analysis: Report of CIOMS Working Group X","year":"2016","author":"Council for International Oraganizations of Medical Sciences","key":"e_1_2_8_50_1"},{"key":"e_1_2_8_51_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(99)04149-5"},{"key":"e_1_2_8_52_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-151-4-200908180-00135"},{"key":"e_1_2_8_53_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.9.830"},{"key":"e_1_2_8_54_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1761"},{"key":"e_1_2_8_55_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2528"},{"key":"e_1_2_8_56_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/68.1.73"},{"key":"e_1_2_8_57_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d4002"},{"key":"e_1_2_8_58_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.15.2008"},{"key":"e_1_2_8_59_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2004.10.012"},{"key":"e_1_2_8_60_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2934"},{"key":"e_1_2_8_61_1","doi-asserted-by":"publisher","DOI":"10.1136\/jamia.2009.002477"},{"key":"e_1_2_8_62_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-012-0009-3"},{"key":"e_1_2_8_63_1","doi-asserted-by":"publisher","DOI":"10.1111\/joim.12159"},{"key":"e_1_2_8_64_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.329.7456.44"},{"key":"e_1_2_8_65_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.294.6580.1119"},{"key":"e_1_2_8_66_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.294.6564.91"},{"key":"e_1_2_8_67_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2328"},{"key":"e_1_2_8_68_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3968"},{"key":"e_1_2_8_69_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwt010"},{"key":"e_1_2_8_70_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2009.394"},{"key":"e_1_2_8_71_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.5620"},{"key":"e_1_2_8_72_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1302834"},{"key":"e_1_2_8_73_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1928"},{"key":"e_1_2_8_74_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1929"},{"key":"e_1_2_8_75_1","unstructured":"RassenJA MoranJ TohD et al.Mini\u2010Sentinel methods evaluating strategies for data sharing and analyses in distributed data settings.2012.https:\/\/www.sentinelinitiative.org\/sites\/deFault\/files\/Methods\/Mini-Sentinel_Methods_Evaluations_Strategies_For_DAta_Sharing_And_Analyses_0.pdf."}],"container-title":["Pharmaceutical Statistics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpst.1908","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pst.1908","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T13:02:32Z","timestamp":1693659752000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.1908"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10,25]]},"references-count":74,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,1]]}},"alternative-id":["10.1002\/pst.1908"],"URL":"https:\/\/doi.org\/10.1002\/pst.1908","archive":["Portico"],"relation":{},"ISSN":["1539-1604","1539-1612"],"issn-type":[{"type":"print","value":"1539-1604"},{"type":"electronic","value":"1539-1612"}],"subject":[],"published":{"date-parts":[[2018,10,25]]},"assertion":[{"value":"2016-12-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}