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
. 2013 Oct;10(10):e1001530.
doi: 10.1371/journal.pmed.1001530. Epub 2013 Oct 15.

A new approach to psychiatric drug approval in Europe

Corrado Barbui  1 , Irene Bighelli
Affiliations

A new approach to psychiatric drug approval in Europe

Corrado Barbui et al. PLoS Med. 2013 Oct.

Abstract

Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bighelli I, Barbui C (2012) What is the European Medicines Agency? Epidemiol Psychiatr Sci 21: 245–247. - PubMed
    1. Duijnhoven RG, Straus SM, Raine JM, de BA, Hoes AW, De Bruin ML (2013) Number of patients studied prior to approval of new medicines: a database analysis. PLoS Med 10: e1001407 doi:10.1371/journal.pmed.1001407 - DOI - PMC - PubMed
    1. Barbui C, Baschirotto C, Cipriani A (2011) EMA must improve the quality of its clinical trial reports. BMJ 342: d2291. - PubMed
    1. Barbui C, Bighelli I (2013) Regulatory science in Europe: the case of schizophrenia trials. Lancet 381 In press. - PubMed
    1. European Medicines Agency (2010) Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available. European Medicines Agency EMA/759784/2010.

LinkOut - more resources