Tran Dat T, Akpinar Ilke, Jacobs Philip
Institute of Health Economics, Edmonton, AB, Canada.
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada.
Pharmacoecon Open. 2020 Jun;4(2):353-359. doi: 10.1007/s41669-019-0161-0.
The objective of this study was to estimate the provincial and nationwide costs of industry-sponsored drug clinical trials (CTs) in Canada.
We used the Aggregate Analysis of ClinicalTrials.gov (AACT) database, and included all industry-sponsored drug CTs that were conducted in Canada and completed in 2016. We estimated the costs of the study drugs using the market price. Estimates of the costs of management and patient services were based on industry contracts.
The sample included 394 CTs that were conducted in 2039 facilities in Canada and provided services for 20,126 Canadian enrollees. Two-thirds of the CTs (277 of 394) were in the non-cancer category. On average, the drug costs per patient were 89,680 Canadian dollars ($Can) during the lifespan of the CTs, and were higher in cancer CTs than in non-cancer CTs ($Can216,876 vs. $Can65,274). The total costs of industry-sponsored drug CTs completed in 2016 was $Can2093.7 million. Drug costs accounted for the majority of this total ($Can1804.9 million). Ontario ($Can781.2 million) and Quebec ($Can757.5 million) had the highest costs.
The costs of industry-sponsored drug CTs completed in 2016 when measured in terms of market prices in Canada were valued at $Can2.1 billion.
本研究的目的是估计加拿大行业赞助的药物临床试验（CT）在省级和全国范围内的成本。
我们使用了临床试验.gov（AACT）数据库的汇总分析，并纳入了所有在加拿大进行且于2016年完成的行业赞助的药物CT。我们使用市场价格估计研究药物的成本。管理和患者服务成本的估计基于行业合同。
样本包括在加拿大2039个机构进行的394项CT，为20126名加拿大参与者提供服务。三分之二的CT（394项中的277项）属于非癌症类别。在CT的整个周期内，每位患者的药物平均成本为89680加元（$Can），癌症CT中的成本高于非癌症CT（$Can216876对$Can65274）。2016年完成的行业赞助药物CT的总成本为$Can2.0937亿。药物成本占总成本的大部分（$Can1.8049亿）。安大略省（$Can7.812亿）和魁北克省（$Can7.575亿）的成本最高。
按照加拿大的市场价格衡量，2016年完成的行业赞助药物CT的成本价值为$Can21亿。
