Amato Antonino, Aringhieri Eugenio, Boccia Stefania, Buccella Filippo, Gorini Barbara, Gramaglia Donatella, Masetti Riccardo, Rossi Paolo, Pelicci Pier Giuseppe
Clinical Trial Center, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.
Farmindustria-Gruppo Biotecnologico, Rome, Italy.
Ann Ist Super Sanita. 2017 Apr-Jun;53(2):104-107. doi: 10.4415/ANN_17_02_05.
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.
即将实施的《欧洲临床试验条例》(欧盟第536/2014号条例)有望推动整个欧盟范围内的临床试验开展,这将要求各国当局通过国家指南为新条例的实施创造最佳条件,以便申办者可能重新将欧洲视为规划临床试验的首选地点。在一次名为“临床研究创新”的会议上,一个专家小组与制药行业、患者组织和意大利监管机构的代表讨论了促进欧洲临床研究竞争力的潜在本地进展,这是鉴于即将实施的关于药品临床试验的欧盟第536/2014号条例。在本文中,我们总结了会议的结果,描述了临床研究模式的特点,并就所有利益相关者可能的参与提出一些建议,以促进研究创新并让患者能够及时获得新药。