Factors associated with successful phase III trials for solid tumors: A systematic review

Background: It is known that the success rates of phase III trials for solid cancers are low. The aim of this study was to investigate factors related to trial design and operation that were associated with the probability of the success of phase III trials for solid cancers based on the latest comp...

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Autores principales:	Yasushi Otsuka, Masayuki Kaneko, Mamoru Narukawa
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Solid cancers Success Enrollment period Phase 3 Systematic review Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9c58e45cd3cb41dfb50879775f916db7
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spelling	oai:doaj.org-article:9c58e45cd3cb41dfb50879775f916db72021-11-20T05:08:07ZFactors associated with successful phase III trials for solid tumors: A systematic review2451-865410.1016/j.conctc.2021.100855https://doaj.org/article/9c58e45cd3cb41dfb50879775f916db72021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001551https://doaj.org/toc/2451-8654Background: It is known that the success rates of phase III trials for solid cancers are low. The aim of this study was to investigate factors related to trial design and operation that were associated with the probability of the success of phase III trials for solid cancers based on the latest comprehensive data. Methods: Relevant clinical trials, started between September 2007 and December 2017, were retrieved from ClinicalTrials.gov. Then, variables related to the selected trials such as types of primary endpoint and duration of trial enrollment were collected from the literature and ClinicalTrials.gov. Based on the collected data, a multivariate logistic regression analysis was conducted to find factors associated with the successful results. Results: Four hundred phase III trials were found eligible for the study. Unsuccessful trials were 207 and successful trials were 193. As a result of multivariate logistic regression analysis, factors that presented a statistically significant relationship were primary endpoint (Odds ratio [OR]: 2.79 [95% CI: 1.59–4.89]), control arm (OR: 3.06 [95% CI: 1.39–6.73]), start year of trial (OR: 3.28 [95% CI: 1.87–5.77]), and duration of trial enrollment (OR: 0.77 [95% CI: 0.60–0.99]). Conclusion: Type of primary endpoints (time-to-event endpoints other than overall survival), control arm (treatments with lower evidence level, placebo or best supportive care), and duration of trial enrollment (faster enrollment speed) were associated with phase III trial success.Yasushi OtsukaMasayuki KanekoMamoru NarukawaElsevierarticleSolid cancersSuccessEnrollment periodPhase 3Systematic reviewMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100855- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Solid cancers Success Enrollment period Phase 3 Systematic review Medicine (General) R5-920
spellingShingle	Solid cancers Success Enrollment period Phase 3 Systematic review Medicine (General) R5-920 Yasushi Otsuka Masayuki Kaneko Mamoru Narukawa Factors associated with successful phase III trials for solid tumors: A systematic review
description	Background: It is known that the success rates of phase III trials for solid cancers are low. The aim of this study was to investigate factors related to trial design and operation that were associated with the probability of the success of phase III trials for solid cancers based on the latest comprehensive data. Methods: Relevant clinical trials, started between September 2007 and December 2017, were retrieved from ClinicalTrials.gov. Then, variables related to the selected trials such as types of primary endpoint and duration of trial enrollment were collected from the literature and ClinicalTrials.gov. Based on the collected data, a multivariate logistic regression analysis was conducted to find factors associated with the successful results. Results: Four hundred phase III trials were found eligible for the study. Unsuccessful trials were 207 and successful trials were 193. As a result of multivariate logistic regression analysis, factors that presented a statistically significant relationship were primary endpoint (Odds ratio [OR]: 2.79 [95% CI: 1.59–4.89]), control arm (OR: 3.06 [95% CI: 1.39–6.73]), start year of trial (OR: 3.28 [95% CI: 1.87–5.77]), and duration of trial enrollment (OR: 0.77 [95% CI: 0.60–0.99]). Conclusion: Type of primary endpoints (time-to-event endpoints other than overall survival), control arm (treatments with lower evidence level, placebo or best supportive care), and duration of trial enrollment (faster enrollment speed) were associated with phase III trial success.
format	article
author	Yasushi Otsuka Masayuki Kaneko Mamoru Narukawa
author_facet	Yasushi Otsuka Masayuki Kaneko Mamoru Narukawa
author_sort	Yasushi Otsuka
title	Factors associated with successful phase III trials for solid tumors: A systematic review
title_short	Factors associated with successful phase III trials for solid tumors: A systematic review
title_full	Factors associated with successful phase III trials for solid tumors: A systematic review
title_fullStr	Factors associated with successful phase III trials for solid tumors: A systematic review
title_full_unstemmed	Factors associated with successful phase III trials for solid tumors: A systematic review
title_sort	factors associated with successful phase iii trials for solid tumors: a systematic review
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/9c58e45cd3cb41dfb50879775f916db7
work_keys_str_mv	AT yasushiotsuka factorsassociatedwithsuccessfulphaseiiitrialsforsolidtumorsasystematicreview AT masayukikaneko factorsassociatedwithsuccessfulphaseiiitrialsforsolidtumorsasystematicreview AT mamorunarukawa factorsassociatedwithsuccessfulphaseiiitrialsforsolidtumorsasystematicreview
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Factors associated with successful phase III trials for solid tumors: A systematic review

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