Abstract 418: A novel animal study software application emulates clinical trials by enabling the conduct of multi-center, asynchronous pre-clinical trials
Authors: Ibsen Eric M. , Kumer Jeffrey L. 
Published: August 2015

Abstract
Just five percent of anticancer therapeutics are approved following completion of positive Phase III clinical trials. The high rate of failure is primarily due to insufficient demonstration of efficacy as opposed to toxicity. This suggests that existing pre-clinical tools and methods are suboptimal predictors of clinical efficacy. For this reason, software tools which are capable of managing and conducting multi-center pre-clinical trials are needed. Results from pre-clinical studies which closely emulate clinical trials are assumed to be more predictive of clinical outcome. To accrue subjects from a genetically diverse patient population and rapidly complete studies, clinical trials are conducted on a global scale at multiple sites, enrolling patients on a rolling, asynchronous basis. The high degree of complexity of such multi-center trials requires powerful software to enable rigorous scheduling practices and oversight as well as standardized and centralized protocol and data management. The use of paper-based and spreadsheet-based approaches to pre-clinical study conduct, has heretofore made multi-center trials with rolling enrollments unfeasible. This is due in large part to the inability of these approaches to manage study task and measurement schedules, their lack of a standardized, centralized protocol management functionality, and the lack of centralized data aggregation, processing and analysis capability. In addition, variability in methods of data collection, processing and analysis, high manual labor costs and an overall lack of standardized nomenclature make spreadsheet-based approaches likewise unsuitable for the conduct of asynchronous, multi-center trials. For the first time, these problems are surmountable with the implementation of a novel, commercially-available animal study workflow software and database. The application manages a trial with arms conducted at multiple study centers around the world. Each center has its own database, which is synchronized to a central database so data acquired at various locations can be aggregated, processed and analyzed. Methodologies for study conduct, analyses and reporting are detailed in a single, centralized protocol, ensuring consistency and uniformity of results across all study centers. Data from animals enrolled on a rolling basis may be automatically aligned relative to its respective enrollment day. The ability for a trial to employ transgenic animals which spontaneously develop tumors, or standard xenografts or patient derived xenografts (PDX), closely emulates the process of asynchronous subject accrual used in clinical trials. Additional functionalities which further enable or facilitate the conduct of Multi-Center Pre-clinical Trials on a global basis will be described.
Citation Format: Eric M. Ibsen, Jeffrey L. Kumer. A novel animal study software application emulates clinical trials by enabling the conduct of multi-center, asynchronous pre-clinical trials. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 418. doi:10.1158/1538-7445.AM2015-418