Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Apr;103(4):564-566.
doi: 10.1002/cpt.899. Epub 2017 Nov 6.

Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

Stefano Ponzano  1 , Kevin Blake  1 , Milton Bonelli  1 , Harald Enzmann  2 ; European Medicines Agency Committee for Human Medicinal Products “First-in-Human Guideline Drafting Group”
Affiliations

Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

Stefano Ponzano et al. Clin Pharmacol Ther. 2018 Apr.

Abstract

The European Medicines Agency (EMA) revises its guideline on minimizing risk in first-in-human trials to reflect changing practice and in light of a recent tragic incident.

PubMed Disclaimer

Comment in

References

    1. Procedure for European Union Guideline and Related Documents within the Pharmaceutical Legislative Framework (EMEA/P/24143/2004 Rev. 1 corr.). European Medicines Agency, London. 2009.
    1. Suntharalingam, G. et al Cytokine storm in a phase 1 trial of the anti‐CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355, 1018–1028 (2006). - PubMed
    1. Strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products. <http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen...> (2017). - PMC - PubMed
    1. Bonini, S. & Rasi, G. First‐in‐human clinical trials — What we can learn from tragic failures. N. Engl. J. Med. 735, 1788–1789 (2016). - PubMed
    1. International Council for Harmonisation (ICH) Safety Guidelines <http://www.ich.org/products/guidelines/safety/article/safety‐guidelines....> (2017).

MeSH terms