{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T13:45:23Z","timestamp":1762177523758,"version":"3.40.5"},"reference-count":15,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2022,9,20]],"date-time":"2022-09-20T00:00:00Z","timestamp":1663632000000},"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":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Traditional approaches to hypothesis testing in comparative post\u2010approval safety and effectiveness studies of medical products are often inadequate because of a limited scope of possible inferences (e.g., superiority or inferiority). Often there is interest in simultaneously testing for superiority, equivalence, inferiority, non\u2010inferiority, and non\u2010superiority, which can be achieved using a partition testing framework. Partition testing only requires selection of an equivalence margin and calculation of a two\u2010sided Wald confidence interval. In addition to permitting a broader range of inferences, the strengths of the approach include: mitigating publication bias, avoiding use of a clinically irrelevant nil hypothesis, and more transparent and impartial appraisal of the clinical importance of a study's findings by pre\u2010specifying an equivalence margin. However, a challenge in implementing the approach can be the process for identifying an equivalence margin. The methodology is illustrated using a published study of the safety of Ondansetron for the off\u2010label treatment of nausea and vomiting during pregnancy. Applying the method to the study results would have led to a conclusion that women exposed to Ondansetron in comparison to those that are not, are equivalent with respect to risk of cardiac malformations and oral clefts. These conclusions are more in line with the magnitude of the observed effects than the conclusions resulting from a traditional inferiority\/superiority testing conducted by the study authors.<\/jats:p>","DOI":"10.1002\/pds.5540","type":"journal-article","created":{"date-parts":[[2022,9,12]],"date-time":"2022-09-12T05:55:06Z","timestamp":1662962106000},"page":"1280-1286","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Partition testing for real\u2010world evidence studies"],"prefix":"10.1002","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1743-429X","authenticated-orcid":false,"given":"Guy","family":"Cafri","sequence":"first","affiliation":[{"name":"Johnson and Johnson Medical Devices and Office of the Chief Medical Officer Medical Device Epidemiology and Real World Data Sciences  New Brunswick New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Wood","sequence":"additional","affiliation":[{"name":"Johnson and Johnson Medical Devices and Office of the Chief Medical Officer Medical Device Epidemiology and Real World Data Sciences  New Brunswick New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua","family":"Gagne","sequence":"additional","affiliation":[{"name":"Harvard T.H. Chan School of Public Health  Boston Massachusetts USA"},{"name":"Epidemiology, Johnson &amp; Johnson  New Brunswick New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,9,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.311.7003.485"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4002"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1214\/aos\/1031689023"},{"key":"e_1_2_9_5_1","unstructured":"ICH Expert Working Group.ICH harmonised tripartite guideline statistical principles for clinical trials. 1998."},{"volume-title":"Modern Epidemiology","year":"2008","author":"Rothman KJ","key":"e_1_2_9_6_1"},{"issue":"308","key":"e_1_2_9_7_1","first-page":"2594","article-title":"Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT statement","volume":"2012","author":"Piaggio G","year":"2010","journal-title":"JAMA"},{"key":"e_1_2_9_8_1","unstructured":"US Food and Drug Administration (FDA).Guidance for industry non\u2010inferiority clinical trials to establish effectiveness. FDA website. Accessed September 10 2021.https:\/\/www.fda.gov\/media\/78504\/download."},{"key":"e_1_2_9_9_1","unstructured":"US Food and Drug Administration (FDA).Guidance for industry diabetes mellitus\u2010 evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Accessed September 10 2021.https:\/\/www.fda.gov\/media\/71297\/download."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1110327"},{"key":"e_1_2_9_11_1","unstructured":"European Medicines Agency.PRAC recommendations on signals. Accessed March 5 2021.https:\/\/www.ema.europa.eu\/en\/documents\/prac-recommendation\/prac-recommendations-signals-adopted-8-11-july-2019-prac-meeting_en.pdf."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.18307"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.19438"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2020.1325"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/00031305.2016.1154108"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10654-016-0149-3"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5540","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5540","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5540","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T07:18:40Z","timestamp":1692515920000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5540"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,20]]},"references-count":15,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1002\/pds.5540"],"URL":"https:\/\/doi.org\/10.1002\/pds.5540","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"type":"print","value":"1053-8569"},{"type":"electronic","value":"1099-1557"}],"subject":[],"published":{"date-parts":[[2022,9,20]]},"assertion":[{"value":"2022-03-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}