摘要：The forthcoming implementation of the European Clinical Trial Regulation (Regulation(EU) No. 536/2014), which is expected to facilitate the conduct of clinical trialsacross the European Union, will require National Authorities to create the best conditionsfor the implementation of the new Regulation through national guidelines, so thatsponsors may reconsider Europe as a prime location for planning clinical trials. Duringa meeting titled “Innovation in Clinical Research”, an expert panel discussed potentiallocal advances fostering competitiveness of European clinical research with representativesof the pharmaceutical industry, patient organisations and Italian regulatory agencyin view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials ofmedicinal products. In this article we summarise the findings of the meeting, describefeatures characterising clinical research patterns and offer some suggestions on the possibleinvolvement of all stakeholders in order to foster research innovation and allow thetimely access to novel medicines for patients.
关键词：European Union; legislation; clinical research
