Abstract

Introduction: In 2015, 452 compounds are in development for asthma and COPD. Drug clinical trials (CTs) in Respiratory Diseases (RDs) play an essential role in promoting the health of the European population and in contributing to the Europe9s economic growth. We describe the current situation of CTs for RDs in Europe as a necessary step to improve the CTs process. Materials and Methods: We used data from public sources (EFPIA,NIH,EUDRA,AIFA) in order to (a)describe CTs activity in Europe by country and therapy area (b)describe the evolution of CTs in RDs in Italy 2007-13. Results: In 2012, 3908 CTs were performed in Europe, 386 in RDs (9,9%). Germany was first in the rank (76 CTs,14% of country CTs), Spain, Italy and France in the last positions (≤ 7% of country CTs). In 2013 Italy performed 9 CTs in RDs (2,1% of country CTs), 33% in phase 2, 66% in phase 3. Not for profit CTs were 28,5% of CTs. Discussion: Drug CTs in RDs account for 10% of CTs in Europe. Spain, Italy and France CTs activity is below the European average. CTs activity in Italy is in the lowest positions among therapeutic areas. Europe has a greater potential for CTs on drugs for RDs, particularly in Spain, France and Italy. To increase CTs on RDs in these countries, specific interventions to make them more attractive and competitive for drug CTs should be implemented.

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