Open AccessTake Care of the Fast‐in‐Human Study
Author(s) -
Hoogdalem EJ
Publication year - 2017
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12437
Subject(s) - safeguarding , drug development , best practice , public relations , event (particle physics) , business , engineering ethics , medicine , management , political science , drug , pharmacology , economics , nursing , physics , quantum mechanics , engineering
Drug developers often evaluate products with an unprecedented mechanism of action, under pressure to bring products to patients fast. The recent tragedy with a fattyacid amide hydrolase inhibitor raises questions on balancing good science and good business while safeguarding safety and ethical standards. Was the issue with processing information rather than data package? Full disclosure and root cause analysis are called for. Recommendations are made to ensure integration of preclinical learning with the clinical plan.