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• W2947016053 abstract "e14576 Background: Decisions to conduct P3 trials are based on evidence of activity from preceding trials. We sought the characteristics of preceding trials that were associated with a positive outcome in subsequent P3 trials of targeted and immunological therapies in oncology. Methods: We identified P3 trials of targeted and immunological therapies in advanced, solid-organ malignancies published from 2005 to 2015, and the preceding trials that were cited as their justification. We extracted characteristics and outcomes of the preceding trials and the subsequent P3 trials. We performed univariable and multivariable analyses to identify characteristics of preceding trials that were associated with a positive outcome in P3 trials. Results: We included 205 P3 trials with 542 citations of preceding trials. The experimental agent evaluated was (P3 trial, preceding trial respectively): small molecule (47%, 39%), immunotherapy (10%, 16%), monoclonal antibody (28%, 32%), hormonal therapy (7%, 6%), and other agent (8%, 6%). The primary endpoint was positive in 40% of P3 trials. The findings of preceding trials were reported ‘positively’ by their authors in 87%, but a priori criteria for judging their findings ‘positive’ were specified in only 74%, and met in only 53%. Characteristics of preceding trials that were associated with a positive primary endpoint in the subsequent P3 trial on multivariable analysis were: conduct in the same tumour type (odds ratio 2.35, 95% CI 1.0 to 5.6, p = 0.05), and sponsored by industry (odds ratio 2.02, 95% CI 1.2 to 3.5, p = 0.01). Conclusions: Researchers designing and conducting phase 2 trials should pre-specify and report criteria for concluding that the findings are ‘positive’. Researchers designing and conducting P3 trials of targeted and immunological therapies should require evidence of activity for the specific type(s) of tumour and therapy in question. [Table: see text]" @default.
• W2947016053 created "2019-06-07" @default.
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• W2947016053 date "2019-05-20" @default.
• W2947016053 modified "2023-09-27" @default.
• W2947016053 title "Characteristics of preceding trials associated with the outcome of subsequent phase III (P3) trials of targeted and immunological therapies in advanced cancers." @default.
• W2947016053 doi "https://doi.org/10.1200/jco.2019.37.15_suppl.e14576" @default.
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