{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:09:21Z","timestamp":1777543761475,"version":"3.51.4"},"reference-count":41,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2012,2,1]],"date-time":"2012-02-01T00:00:00Z","timestamp":1328054400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:p>Background In active run-in trials, where patients may be excluded after a run-in period based on their response to the treatment, it is implicitly assumed that patients have individual treatment effects. If individual patient data are available, active run-in trials can be modelled using patient-specific random effects. With more than one trial on the same medication available, one can obtain a more precise overall treatment effect estimate.<\/jats:p>\n                  <jats:p>Methods We present a model for joint analysis of a two-sequence, four-period cross-over trial (AABB\/BBAA) and a three-sequence, two-period active run-in trial (AB\/AA\/A), where the aim is to investigate the effect of a new treatment for patients with pain due to osteoarthritis.<\/jats:p>\n                  <jats:p>Results Our approach enables us to separately estimate the direct treatment effect for all patients, for the patients excluded after the active run-in trial prior to randomisation, and for the patients who completed the active run-in trial. A similar model approach can be used to analyse other types of run-in trials, but this depends on the data and type of other trials available.<\/jats:p>\n                  <jats:p>Limitations We assume equality of the various carry-over effects over time.<\/jats:p>\n                  <jats:p>Conclusions The proposed approach is flexible and can be modified to handle other designs. Our results should be encouraging for those responsible for planning cost-efficient clinical development programmes.<\/jats:p>","DOI":"10.1177\/1740774511430714","type":"journal-article","created":{"date-parts":[[2012,2,2]],"date-time":"2012-02-02T13:20:02Z","timestamp":1328188802000},"page":"164-175","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["An approach to combining parallel and cross-over trials with and without run-in periods using individual patient data"],"prefix":"10.1177","volume":"9","author":[{"given":"Ingunn F","family":"Tvete","sequence":"first","affiliation":[{"name":"Norwegian Computing Center \u2013 SAMBA, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inge C","family":"Olsen","sequence":"additional","affiliation":[{"name":"Smerud Medical Research International AS, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morten W","family":"Fagerland","sequence":"additional","affiliation":[{"name":"Oslo University Hospital \u2013 Unit of Biostatistics and Epidemiology, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nils","family":"Meland","sequence":"additional","affiliation":[{"name":"Smerud Medical Research International AS, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magne","family":"Aldrin","sequence":"additional","affiliation":[{"name":"Norwegian Computing Center \u2013 SAMBA, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Knut T","family":"Smerud","sequence":"additional","affiliation":[{"name":"Smerud Medical Research International AS, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Holden","sequence":"additional","affiliation":[{"name":"Norwegian Computing Center \u2013 SAMBA, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,2,1]]},"reference":[{"key":"bibr1-1740774511430714","volume-title":"ICH Topic E9. 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