Leclerc Jean-Marie, Laberge Normand, Marion Jean
Hôpital Ste-Justine, Montreal, QC, Former Sr. VP, Clinical and Regulatory Affairs and Chief Scientific Officer, Novartis Pharmaceuticals Canada Inc., Dorval, QC.
Healthc Policy. 2012 Nov;8(2):88-104.
Industry-sponsored clinical trials play a key role in the development of therapies. This survey suggests that between 2005 and 2010, research-based pharmaceutical firms worldwide initiated fewer trials and recruited fewer subjects annually. In contrast, at the country level, the clinical trial activity of such firms increased in emerging countries and in Japan. Canada's trend in the number of new trials followed that of the global industry, but the trend in new sites and newly recruited subjects fell below the global rate. Informal comparisons point to potential issues for Canada in such areas as site capacity, cost per subject and time to first subject-in. When compared to certain Western European countries and the United States, Canada remained well positioned on a number of metrics. Nonetheless, Canada faces mounting challenges from both traditional locations and emerging countries and may require coordinated efforts to remain a place of choice to conduct trials.
行业资助的临床试验在疗法开发中发挥着关键作用。这项调查表明，2005年至2010年间，全球以研究为基础的制药公司每年启动的试验减少，招募的受试者也减少。相比之下，在国家层面，这些公司在新兴国家和日本的临床试验活动有所增加。加拿大新试验数量的趋势与全球行业一致，但新试验点和新招募受试者的趋势低于全球水平。非正式比较指出了加拿大在试验点能力、每个受试者的成本以及首个受试者入组时间等领域可能存在的问题。与某些西欧国家和美国相比，加拿大在一些指标上仍处于有利地位。尽管如此，加拿大正面临来自传统地区和新兴国家的越来越大的挑战，可能需要协同努力才能继续成为进行试验的首选之地。
