{"id":{"repo_id":"iupui","oai_identifier":"oai:scholarworks.indianapolis.iu.edu:1805/42019"},"canonical_url":"https://search.dev.ndltd.org/etd/iupui/oai:scholarworks.indianapolis.iu.edu:1805/42019","repository":{"repo_id":"iupui","name":"IUPUI","base_url":"https://scholarworks.indianapolis.iu.edu/server/oai/request"},"display":{"title":"Modified 3+3 Design for MTD Re-estimation","abstract":"The 3+3 clinical trial design is one of the most popular dose-finding designs used in phase I oncology trials to identify the maximum tolerated dose (MTD) for new treatment regimens. While this design is widely used due to its simplicity , it has some notable limitations, including a maximum of six patients per dose level and fixed target toxicity rates. To address these issues, we propose a modified 3+3 design that extends the traditional 3+3 design by treating the remaining patients at the MTD level for additional dose-limiting toxicity (DLT) assessment. This modification allows for a more flexible and accurate way to identify the MTD, enhanced by the use of isotonic regression to calculate DLT rates. To compare the modified 3+3 designs and the traditional 3+3 design, computer simulation studies have been carried out under various dose-toxicity scenarios. The results show that the modified 3+3 design yields higher accuracy in MTD identification.","abstract_html":"The 3+3 clinical trial design is one of the most popular dose-finding designs used in phase I oncology trials to identify the maximum tolerated dose (MTD) for new treatment regimens. While this design is widely used due to its simplicity , it has some notable limitations, including a maximum of six patients per dose level and fixed target toxicity rates. To address these issues, we propose a modified 3+3 design that extends the traditional 3+3 design by treating the remaining patients at the MTD level for additional dose-limiting toxicity (DLT) assessment. This modification allows for a more flexible and accurate way to identify the MTD, enhanced by the use of isotonic regression to calculate DLT rates. To compare the modified 3+3 designs and the traditional 3+3 design, computer simulation studies have been carried out under various dose-toxicity scenarios. The results show that the modified 3+3 design yields higher accuracy in MTD identification.","abstract_has_math":false,"creators":["Zhang, Tianshu"],"institution":null,"degree_name":null,"degree_level":null,"degree_discipline":null,"degree_department":null,"school":null,"contributors":[],"advisors":["Zang, Yong"],"committee_chairs":[],"committee_members":[],"year":2024,"date_issued":"2024-06","date_published":"2024-06","updated_at":"2026-07-24T02:40:35Z","subjects":["Phase I clinical trial","3+3 design","maximum tolerated dose (MTD)","dose-limiting toxicity (DLT)"],"languages":["en_US"],"rights":[],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier.uri","label":"Identifier URI","values":["https://doi.org/10.7912/Q5YF-J421"],"render_values":[{"text":"https://doi.org/10.7912/Q5YF-J421","href":"https://doi.org/10.7912/Q5YF-J421","code":true}]}]},"links":{"outbound_url":"https://hdl.handle.net/1805/42019","outbound_label":"Handle","outbound_source":"dc:identifier.uri"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor.advisor","label":"Advisor","values":["Zang, Yong"]},{"key":"dc:contributor.other","label":"Dc Contributor Other","values":["Han, Yan","Liu, Ziyue"]},{"key":"dc:creator","label":"Author","values":["Zhang, Tianshu"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.accessioned","label":"Dc Date Accessioned","values":["2024-07-02T14:14:16Z"]},{"key":"dc:date.available","label":"Dc Date Available","values":["2024-07-02T14:14:16Z"]},{"key":"dc:date.issued","label":"Date","values":["2024-06"]},{"key":"dc:type","label":"Dc Type","values":["Thesis"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Phase I clinical trial","3+3 design","maximum tolerated dose (MTD)","dose-limiting toxicity (DLT)"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language.iso","label":"Language (ISO)","values":["en_US"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier.uri","label":"Identifier URI","values":["https://hdl.handle.net/1805/42019","https://doi.org/10.7912/Q5YF-J421"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description","label":"Description","values":["Indiana University-Purdue University Indianapolis (IUPUI)"]},{"key":"dc:description.abstract","label":"Abstract","values":["The 3+3 clinical trial design is one of the most popular dose-finding designs used in phase I oncology trials to identify the maximum tolerated dose (MTD) for new treatment regimens. While this design is widely used due to its simplicity , it has some notable limitations, including a maximum of six patients per dose level and fixed target toxicity rates. To address these issues, we propose a modified 3+3 design that extends the traditional 3+3 design by treating the remaining patients at the MTD level for additional dose-limiting toxicity (DLT) assessment. This modification allows for a more flexible and accurate way to identify the MTD, enhanced by the use of isotonic regression to calculate DLT rates. To compare the modified 3+3 designs and the traditional 3+3 design, computer simulation studies have been carried out under various dose-toxicity scenarios. The results show that the modified 3+3 design yields higher accuracy in MTD identification."]},{"key":"dc:title","label":"Title","values":["Modified 3+3 Design for MTD Re-estimation"]}]}],"canonical_facts":{"dc:contributor.advisor":["Zang, Yong"],"dc:contributor.other":["Han, Yan","Liu, Ziyue"],"dc:creator":["Zhang, Tianshu"],"dc:date.accessioned":["2024-07-02T14:14:16Z"],"dc:date.available":["2024-07-02T14:14:16Z"],"dc:date.issued":["2024-06"],"dc:description":["Indiana University-Purdue University Indianapolis (IUPUI)"],"dc:description.abstract":["The 3+3 clinical trial design is one of the most popular dose-finding designs used in phase I oncology trials to identify the maximum tolerated dose (MTD) for new treatment regimens. While this design is widely used due to its simplicity , it has some notable limitations, including a maximum of six patients per dose level and fixed target toxicity rates. To address these issues, we propose a modified 3+3 design that extends the traditional 3+3 design by treating the remaining patients at the MTD level for additional dose-limiting toxicity (DLT) assessment. This modification allows for a more flexible and accurate way to identify the MTD, enhanced by the use of isotonic regression to calculate DLT rates. To compare the modified 3+3 designs and the traditional 3+3 design, computer simulation studies have been carried out under various dose-toxicity scenarios. The results show that the modified 3+3 design yields higher accuracy in MTD identification."],"dc:identifier.uri":["https://hdl.handle.net/1805/42019","https://doi.org/10.7912/Q5YF-J421"],"dc:language.iso":["en_US"],"dc:subject":["Phase I clinical trial","3+3 design","maximum tolerated dose (MTD)","dose-limiting toxicity (DLT)"],"dc:title":["Modified 3+3 Design for MTD Re-estimation"],"dc:type":["Thesis"]},"updated_at":"2026-07-24T02:40:35Z"}