An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials

Clin Pharmacol Ther. 2018 Apr;103(4):566-569. doi: 10.1002/cpt.984. Epub 2017 Dec 29.

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.

MeSH terms

  • Clinical Trials as Topic* / ethics
  • Clinical Trials as Topic* / legislation & jurisprudence
  • Clinical Trials as Topic* / standards
  • Drug Development*
  • Drug Industry*
  • Drug and Narcotic Control / methods*
  • European Union
  • Guidelines as Topic*
  • Humans
  • Therapeutic Human Experimentation* / ethics
  • Therapeutic Human Experimentation* / legislation & jurisprudence