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From Lab to Clinic: Effect of Academia–Industry Collaboration Characteristics on Oncology Phase 1 Trial Entry

机译:从实验室到临床:学术界-产业合作特征对肿瘤学 1 期试验进入的影响

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摘要

This study investigated the success rate of Phase 1 clinical trial entry and the factors influencing it in oncology projects involving academia–industry collaboration during the discovery and preclinical stages. A total of 344 oncology projects in the discovery stage and 360 in the preclinical stage, initiated through collaborations with universities or hospitals between 2015 and 2019, were analyzed. The Phase 1 clinical trial entry success rates for oncology collaborative projects were 9.9% from the discovery stage and 24.2% from the preclinical stage. For discovery stage contracts, strong statistical significance was observed for contract type (co‐development OR 16.45, p = 0.008; licensing OR 42.43, p = 0.000) and technology (cell or gene therapy OR 3.82, p = 0.008). In contrast, for preclinical stage contracts, significant changes were noted for cancer type (blood cancer OR 2.24, p = 0.004), while the year of contract signing showed a relatively weak statistical significance (OR 1.24, p = 0.021). No significant changes were observed concerning partner firm size and the partnership territory. This study sheds light on how the characteristics of partnerships influence the success rates of early‐phase research, providing valuable insights for future strategic planning in oncology drug development.
机译:本研究调查了 1 期临床试验进入的成功率以及在发现和临床前阶段涉及学术界和工业界合作的肿瘤学项目中的影响因素。共分析了 344 年至 2015 年间通过与大学或医院合作启动的 360 个处于发现阶段的肿瘤学项目和 2019 个处于临床前阶段的肿瘤学项目。肿瘤合作项目的 1 期临床试验进入成功率为发现阶段的 9.9% 和临床前阶段的 24.2%。对于发现阶段合同,合同类型 (共同开发 OR 16.45,p = 0.008;许可 OR 42.43,p = 0.000) 和技术 (细胞或基因治疗 OR 3.82,p = 0.008) 观察到很强的统计显着性。相比之下,对于临床前阶段合同,癌症类型发生了显着变化 (血癌 OR 2.24,p = 0.004),而合同签订年份显示出相对较弱的统计显着性 (OR 1.24,p = 0.021)。未观察到合伙人公司规模和合伙区域发生重大变化。本研究阐明了合作伙伴关系的特征如何影响早期研究的成功率,为肿瘤药物开发的未来战略规划提供了有价值的见解。

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