Lassale Catherine, Sibenaler Claire, Béhier Jehan-Michel, Plétan Yannick, Courcier Soizic
Les Entreprises du Médicament, Paris, France.
Therapie. 2008 Sep-Oct;63(5):345-57. doi: 10.2515/therapie:2008061. Epub 2009 Jan 21.
In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Nineteen companies (61.9 % of the French market) have participated in the current survey which included 385 international phase II and III clinical studies, 77 countries, 29,708 centres and 312,835 patients (included in 2006/2007). France (400 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2006, France has improved administrative processes and reduced deadlines for hospital contracts. Protocols are now to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. Its performance in early phases, oncology/hematology and vaccines/anti-infectious contribute to the attractiveness of France in international clinical research.
为评估法国开展国际临床试验的吸引力，每两年对总部位于法国或在法国设有分支机构的制药公司进行一次调查。19家公司（占法国市场的61.9%）参与了此次调查，调查涵盖了2006/2007年期间的385项国际II期和III期临床研究、77个国家、29708个中心和312835名患者。法国（每百万居民中有400名患者）在欧洲招募情况最佳的国家中排名第二，仅次于斯堪的纳维亚半岛国家。自2006年以来，法国改进了行政流程，缩短了医院合同的审批期限。现在，根据欧洲指令，法国当局（法国药品安全局和医疗保险机构）应在60天内批准试验方案。法国在早期阶段、肿瘤学/血液学以及疫苗/抗感染领域的表现提升了其在国际临床研究中的吸引力。
