Using a Federated Network of Real-World Data to Optimize Clinical Trials Operations

作者：Ümit Topaloĝlu, Matvey B. Palchuk · 发表于：JCO Clinical Cancer Informatics · 年份：2018 · DOI：10.1200/cci.17.00067 · 被引用次数：363 · 研究领域：Ethics in Clinical Research、Health Systems, Economic Evaluations, Quality of Life、Statistical Methods in Clinical Trials

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, H...