{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:02:46Z","timestamp":1790046166119,"version":"4.0.1"},"reference-count":34,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"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":["Pharmaceutical Statistics"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The estimand framework proposes different strategies to address intercurrent events. The treatment policy strategy seems to be the most favoured as it is closely aligned with the pre\u2010addendum intention\u2010to\u2010treat principle. All data for all patients should ideally be collected; however, in reality patients may withdraw from a study leading to missing data. This needs to be dealt with as part of the estimation. A common intercurrent event we focus on is treatment discontinuation. Several areas of research have been conducted exploring models to estimate the estimand when intercurrent events are handled using a treatment policy strategy; however, the research is limited for binary endpoints. We explore different retrieved dropout models, where post\u2010intercurrent event, the observed data can be used to multiply impute the missing post\u2010intercurrent event data. We compare our proposed models to a simple imputation model that makes no distinction between the pre\u2010 and post\u2010intercurrent event data, and assess varying statistical properties through a simulation study. We then provide an example of how retrieved dropout models were used in practice for Phase 3 clinical trials in rheumatoid arthritis. From the models explored, we conclude that a simple retrieved dropout model including an indicator for whether or not the intercurrent event occurred is the most pragmatic choice. However, at least 50% of observed post\u2010intercurrent event data is required for these models to work well. Therefore, the suitability of implementing this model in practice will depend on the amount of observed post\u2010intercurrent event data available and missing data.<\/jats:p>","DOI":"10.1002\/pst.70070","type":"journal-article","created":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T06:10:12Z","timestamp":1770444612000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Using Off\u2010Treatment Sequential Multiple Imputation for Binary Outcomes to Address Intercurrent Events Handled by a Treatment Policy Strategy"],"prefix":"10.1002","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2578-5778","authenticated-orcid":false,"given":"Sunita","family":"Rehal","sequence":"first","affiliation":[{"name":"GlaxoSmithKline  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4120-9727","authenticated-orcid":false,"given":"Nicky","family":"Best","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Watts","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1443-5999","authenticated-orcid":false,"given":"Thomas","family":"Drury","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,6]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"\u201cInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Ich Harmonised Guideline Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1) Final version \u201d(2019)."},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2299"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1910"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2189"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/19466315.2019.1689845"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2411"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2472"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2416"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.10301"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2204"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.9203"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/17407745231176773"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1047"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2023-224482"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"e_1_2_12_17_1","unstructured":"Guidance D \u201cRheumatoid\u2010Arthritis\u2014Developing\u2010Drug\u2010Products\u2010for\u2010Treatment \u201d(2013)."},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12561-016-9146-z"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-019-0793-x"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470316696"},{"key":"e_1_2_12_21_1","unstructured":"J. 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