Abstract

Abstract A 2012 study published by Amgen researchers found that 90% of the in vivo oncology studies were not reproducible. Historically, 95% of post-phase III oncology clinical trial therapies failed to receive regulatory approval due to a lack of demonstrated efficacy, not toxicity. The overwhelming lack of reproducible data underscores the dire need to critically examine our current standard animal study conduct processes for areas of potential improvement. In today’s competitive climate, researchers must identify the causes of poor animal study irreproducibility and implement meaningful and effective solutions. Recently, questions and debates concerning the validity of preclinical science data have resulted in multiple published reviews on the problem. Fortunately, as covered in this presentation, cost-effective technology exists to mitigate this “Crisis of Animal Study Irreproducibility”. This presentation covers: The factors contributing to poor animal study reproducibility. Publicly-available and online resources and practically-applicable concepts, such as the ARRIVE guidelines, PHISPS protocols, and the N3R Design Assistant. Attendees receive first-hand experiences with a variety of animal study conduct approaches and commercially-available animal study workflow software applications, along with a summary of each tool’s direct and indirect impacts on the causes of animal study irreproducibility. Exploration of how these concepts are applied in one Animal Study Workflow Software to solve problems, improve animal study reproducibility and faithfully preserve detailed study results for future access.

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