ARTICLE | Strategy

Articulating standards

Why researchers don't comply with FDA preclinical guidelines

December 10, 2015 8:00 AM UTC

While the failure of companies to reproduce preclinical studies in the literature - often dubbed the "reproducibility crisis" - has left stakeholders calling for preclinical research standards, a meta-analysis out of the University of Pennsylvania has shown that in the field of cartilage repair, where such standards already exist, researchers haven't been following them. Instead of having blanket guidelines, the authors want FDA and NIH to fund centers that can run standardized protocols for academic investigators.

Unlike most disease areas, which lack detailed preclinical guidelines, cartilage repair has three sets of standards. The American Society for Testing and Materials (ASTM), FDA and EMA each began publishing guidance documents for how to conduct large animal studies in 2005, 2007 and 2008, respectively. ASTM is an international organization that enlists experts to create voluntary consensus standards across diverse industries. ...