Recommendations toward a human pathway-based approach to disease research

Lindsay J Marshall; Christopher P Austin; Warren Casey; Suzanne C Fitzpatrick; Catherine Willett

doi:10.1016/j.drudis.2018.05.038

Recommendations toward a human pathway-based approach to disease research

Drug Discov Today. 2018 Nov;23(11):1824-1832. doi: 10.1016/j.drudis.2018.05.038. Epub 2018 Jun 2.

Authors

Lindsay J Marshall¹, Christopher P Austin², Warren Casey³, Suzanne C Fitzpatrick⁴, Catherine Willett⁵

Affiliations

¹ Humane Society International, The Humane Society of the United States, 700 Professional Drive, Gaithersburg, MD 20879, USA. Electronic address: lmarshall@hsi.org.
² Office of the Director, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20817, USA.
³ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, USA; National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC 27709, USA.
⁴ Center for Food Safety and Applied Nutrition, FDA, Harvey W. Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740, USA.
⁵ Humane Society International, The Humane Society of the United States, 700 Professional Drive, Gaithersburg, MD 20879, USA.

PMID: 29870792
DOI: 10.1016/j.drudis.2018.05.038

Abstract

Failures in the current paradigm for drug development have resulted in soaring research and development costs and reduced numbers of new drug approvals. Over 90% of new drug programs fail, the majority terminated at the level of Phase 2/3 clinical trials, largely because of efficacy failures or unexplained toxicity. A recent workshop brought together members from research institutions, regulatory agencies, industry, academia, and nongovernmental organizations to discuss how existing programs could be better applied to understanding human biology and improving drug discovery. Recommendations include increased emphasis on human relevance, better access and curation of data, and improved interdisciplinary and international collaboration.

Publication types

Review

MeSH terms

Drug Approval / methods*
Drug Discovery / economics*
Drug Discovery / methods*
Drug Discovery / statistics & numerical data
Drug Industry / methods*
Drug Industry / statistics & numerical data
Health Planning Guidelines*
Humans