Yang Wonseok, Lee Sang-Won
School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, Republic of Korea.
Clin Transl Sci. 2025 Jan;18(1):e70135. doi: 10.1111/cts.70135.
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.
本研究调查了在发现阶段和临床前阶段涉及产学研合作的肿瘤学项目中,进入1期临床试验的成功率及其影响因素。分析了2015年至2019年期间通过与大学或医院合作启动的344个处于发现阶段的肿瘤学项目和360个处于临床前阶段的肿瘤学项目。肿瘤学合作项目从发现阶段进入1期临床试验的成功率为9.9%,从临床前阶段进入的成功率为24.2%。对于发现阶段的合同,在合同类型(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)方面观察到很强的统计学显著性。相比之下,对于临床前阶段的合同,在癌症类型方面有显著变化(血液癌症,OR = 2.24,p = 0.004),而合同签订年份的统计学显著性相对较弱(OR = 1.24,p = 0.021)。在合作伙伴公司规模和合作地区方面未观察到显著变化。本研究揭示了合作特征如何影响早期研究的成功率,为肿瘤学药物开发的未来战略规划提供了有价值的见解。