论文部分内容阅读
药物经济学的评价贯穿在药物上市前的Ⅱ期、Ⅲ期临床试验阶段和上市后的Ⅳ期临床研究阶段。在Ⅱ期的临床随机对照试验阶段,可以同时收集有关临床成本和药物的费用资料,进行所谓“头对头”的药物比较,评价两者的成本-效果或成本效用的结果。在扩大的Ⅲ期研究中,可以进一步扩大试验对象,了解新药的临床疗效和安全性。药物经济学评价报告可以作为新药申报、评审、定价、补偿的循证依据。在上市后的Ⅳ期临床试验中可以应用病例
The evaluation of pharmacoeconomics runs through Phase II, Phase III clinical trials and phase IV clinical studies after the drug is marketed. In Phase II clinical randomized controlled trials, cost data on clinical costs and medications can be collected together to make so-called “head-to-head” drug comparisons to evaluate the cost-effectiveness or cost-effectiveness of both. In the enlarged phase III study, we can further expand the test subjects to understand the clinical efficacy and safety of new drugs. Pharmacoeconomic evaluation report can be used as evidence-based evidence of new drug application, review, pricing and compensation. In the post-market phase IV clinical trials can be applied cases