Scientific Publications by FDA Staff

ALTEX 2013;30(1):74-103

Evidence-based toxicology for the 21st century: opportunities and challenges.

Stephens ML, Andersen M, Becker RA, Betts K, Boekelheide K, Carney E, Chapin R, Devlin D, Fitzpatrick S, Fowle JR 3rd, Harlow P, Hartung T, Hoffmann S, Holsapple M, Jacobs A, Judson R, Naidenko O, Pastoor T, Patlewicz G, Rowan A, Scherer R, Shaikh R, Simon T, Wolf D, Zurlo J

The Evidence-based Toxicology Collaboration (EBTC) was established recently to translate evidence-based approaches from medicine and health care to toxicology in an organized and sustained effort. The EBTC held a workshop on "Evidence-based Toxicology for the 21st Century: Opportunities and Challenges" in Research Triangle Park, North Carolina, USA on January 24-25, 2012. The presentations largely reflected two EBTC priorities: to apply evidence-based methods to assessing the performance of emerging pathway-based testing methods consistent with the 2007 National Research Council report on "Toxicity Testing in the 21st Century" as well as to adopt a governance structure and work processes to move that effort forward. The workshop served to clarify evidence-based approaches and to provide food for thought on substantive and administrative activities for the EBTC. Priority activities include conducting pilot studies to demonstrate the value of evidence-based approaches to toxicology, as well as conducting educational outreach on these approaches.