A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness

Antonino Amato, Eugenio Aringhieri, Stefania Boccia, Filippo Buccella, Barbara Gorini, Donatella Gramaglia, Riccardo Masetti, Paolo Rossi, Pier Giuseppe Pelicci

Research output: Contribution to journalReview article

Abstract

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

Original languageEnglish
Pages (from-to)104-107
Number of pages4
JournalAnnali dell'Istituto Superiore di Sanita
Volume53
Issue number2
DOIs
Publication statusPublished - Jan 1 2017

Keywords

  • Clinical research
  • European Union
  • Legislation

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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