An Industry Perspective on the 2017 EMA Guideline on First‐in‐Human and Early Clinical Trials. Issue 4 (29th December 2017)

• Record Type: Journal Article
• Authors: DeGeorge, Joseph; Robertson, Sarah; Butler, Lynne; Derzi, Mazin; Stoch, S. Aubrey; Diaz, Dolores; Hartke, James; Guzzie‐Peck, Peggy; Mortimer‐Cassen, Elisabeth; Bogdanffy, Matthew; Will, Yvonne; Greene, Nigel
• Is Part Of: Clinical pharmacology & therapeutics. Volume 103:Issue 4(2018)
• Page Start: 566
• Page End: 569
• Publication Date: 2017-12-29
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.984
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : 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.