{"title":"From Lab to Clinic: Effect of Academia–Industry Collaboration Characteristics on Oncology Phase 1 Trial Entry","authors":"Wonseok Yang, Sang-Won Lee","doi":"10.1111/cts.70135","DOIUrl":null,"url":null,"abstract":"<p>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, <i>p</i> = 0.008; licensing OR 42.43, <i>p</i> = 0.000) and technology (cell or gene therapy OR 3.82, <i>p</i> = 0.008). In contrast, for preclinical stage contracts, significant changes were noted for cancer type (blood cancer OR 2.24, <i>p</i> = 0.004), while the year of contract signing showed a relatively weak statistical significance (OR 1.24, <i>p</i> = 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.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 1","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730079/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cts-Clinical and Translational Science","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/cts.70135","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
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和临床前阶段涉及产学研合作的肿瘤项目中,进入i期临床试验的成功率及其影响因素。2015年至2019年期间,通过与大学或医院合作启动的肿瘤项目中,共有344个处于发现阶段,360个处于临床前阶段。肿瘤合作项目的1期临床试验进入成功率在发现阶段为9.9%,在临床前阶段为24.2%。对于发现阶段合同,合同类型有很强的统计学意义(共同开发OR为16.45,p = 0.008;许可(OR 42.43, p = 0.000)和技术(OR 3.82, p = 0.008)。而在临床前分期合同中,癌症类型差异有统计学意义(OR 2.24, p = 0.004),合同签订年份差异有统计学意义(OR 1.24, p = 0.021)。在合伙人公司规模和合伙人领域方面没有观察到显著的变化。本研究揭示了合作伙伴关系的特点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。
期刊介绍:
Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.