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An Industry Perspective on the 2017 EMA Guideline on First‐in‐Human and Early Clinical Trials
Author(s) -
DeGeorge Joseph,
Robertson Sarah,
Butler Lynne,
Derzi Mazin,
Stoch S. Aubrey,
Diaz Dolores,
Hartke James,
GuzziePeck Peggy,
MortimerCassen Elisabeth,
Bogdanffy Matthew,
Will Yvonne,
Greene Nigel
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.984
Subject(s) - guideline , clinical trial , agency (philosophy) , perspective (graphical) , medicine , intensive care medicine , business , risk analysis (engineering) , computer science , pathology , sociology , artificial intelligence , social science
The European Medicines Agency (EMA) in 2017 issued a revised guideline on nonclinical and clinical aspects of first‐in‐human (FIH) and early clinical trials (CTs). External input was solicited during a draft comment phase, and although some industry suggestions were adopted, others were not. We agree that subject safety is of utmost priority, and believe that minimizing risk must be balanced with efficient and informative study designs to bring new medicines to patients.