Topaloglu Umit, Palchuk Matvey B
Umit Topaloglu, Wake Forest School of Medicine, Winston Salem, NC; and Matvey B. Palchuk, TriNetX, Cambridge, MA.
JCO Clin Cancer Inform. 2018 Dec;2:1-10. doi: 10.1200/CCI.17.00067.
Clinical trials, whether industry, cooperative group sponsored, or investigator initiated, have an unacceptable rate of failure as a result of the inability to recruit sufficient numbers of patients. Even those trials that are completed often require time-consuming protocol amendments to achieve accrual goals. These inefficiencies in clinical trial research result in increasing costs and prolong the time needed to bring improved treatments to cancer clinical practice. TriNetX has developed a clinical research collaboration platform-deployed by a federated network of health care organizations (HCOs), pharmaceutical firms (Pharma), and contract research organizations (CROs)-to enable data-driven clinical research study design to reduce accrual failure and protocol amendment. Currently, the network extends to 55 HCOs and covers 84 million patients, mostly within the United States, but with a growing international presence. (Many of the HCOs in United States are Clinical and Translational Science Awardees and/or National Cancer Institute-designated cancer centers.) The TriNetX business model includes Pharma and the CROs as sponsors whose subscriptions financially support the network, including the software and hardware costs of the HCOs. Furthermore, as each HCO network member has their data harmonized with the TriNetX model upon joining, data sharing among them does not require any technical processes to establish connectivity. To date, on the basis of the data on the network, HCOs have been presented approximately 757 studies by Pharma and CROs, and four data-sharing subnetworks have been formed among member HCOs.
无论是由行业、合作组织赞助还是由研究者发起的临床试验，由于无法招募到足够数量的患者，其失败率都令人难以接受。即使是那些完成的试验，往往也需要耗时的方案修正才能实现入组目标。临床试验研究中的这些低效率导致成本增加，并延长了将改进后的治疗方法应用于癌症临床实践所需的时间。TriNetX开发了一个临床研究合作平台，该平台由医疗保健组织（HCO）、制药公司（Pharma）和合同研究组织（CRO）的联合网络部署，以实现数据驱动的临床研究设计，减少入组失败和方案修正。目前，该网络已扩展到55个HCO，覆盖8400万患者，大部分在美国境内，但国际影响力也在不断扩大。（美国的许多HCO是临床和转化科学奖获得者和/或国家癌症研究所指定的癌症中心。）TriNetX的商业模式包括Pharma和CRO作为赞助商，其订阅为网络提供资金支持，包括HCO的软件和硬件成本。此外，由于每个HCO网络成员在加入时都将其数据与TriNetX模型进行了统一，因此它们之间的数据共享不需要任何技术流程来建立连接。迄今为止，基于网络上的数据，HCO已收到Pharma和CRO提供的约757项研究，成员HCO之间已形成了四个数据共享子网。
