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Furthermore, if there is little hope of ultimately demonstrating benefit, the study may be terminated on either ethical or economic grounds. Design modifications may be made based on either blinded or unblinded analyses. Since observed patterns of recruitment and patient outcomes may differ from those required by standard methods, specialized tools may be required to perform the necessary computations. In this paper we demonstrate how the Markov chain model of Lakatos can accommodate arbitrary observed patterns of recruitment, hazard rates, and other design parameters for performing mid\u2010course corrections in trials with survival outcomes. Copyright \u00a9 2003 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/sim.1576","type":"journal-article","created":{"date-parts":[[2003,10,31]],"date-time":"2003-10-31T15:01:41Z","timestamp":1067612501000},"page":"3431-3447","source":"Crossref","is-referenced-by-count":14,"title":["Methods for mid\u2010course corrections in clinical trials with survival outcomes"],"prefix":"10.1002","volume":"22","author":[{"given":"Thomas D.","family":"Cook","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2003,10,29]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780142007"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980115)17:1<89::AID-SIM730>3.0.CO;2-D"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.733"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.532"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.00190.x"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980730)17:14<1551::AID-SIM868>3.0.CO;2-E"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.00853.x"},{"key":"e_1_2_1_9_2","unstructured":"U.S. Food and Drug Administration.Draft guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees. 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