2011 - 2020年加拿大卫生部批准的新药治疗价值预测：一项横断面研究。
Prediction of therapeutic value of new drugs approved by health Canada from 2011-2020: A cross-sectional study.
作者信息
Lexchin Joel
机构信息
School of Health Policy and Management, York University, Toronto, Canada.
Faculty of Medicine, University of Toronto, Toronto, Canada.
出版信息
JRSM Open. 2023 May 24;14(5):20542704231166620. doi: 10.1177/20542704231166620. eCollection 2023 May.
OBJECTIVES
To examine whether a combination of three characteristics of new drugs - review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value.
DESIGN
Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020.
SETTING
Canada.
PARTICIPANTS
New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available.
MAIN OUTCOME MEASURES
Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug.
RESULTS
Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating.
CONCLUSION
This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.
目的
研究新药的三个特征——审评类型、上市前试验结果（替代指标或临床指标）和同类首创——的组合是否与显著的治疗价值相关。
设计
对2011年1月1日至2020年12月31日期间加拿大卫生部批准的新药进行横断面分析。
地点
加拿大。
参与者
加拿大卫生部批准的新药，且有治疗评估、试验结果和同类首创地位的数据。
主要观察指标
根据每种药物具备这三个特征的数量，划分治疗价值的分布情况（重大、中等、微小或无）。
结果
加拿大卫生部批准了340种药物，其中243种有可供分析的数据。如果三种特征都具备，20种药物中有10种具有重大治疗评级。相反，如果三种特征都不具备，37种药物中只有2种具有重大治疗评级。
结论
本研究引入了一种新的评估方法，用于确定新药是否具有重大治疗价值，该方法似乎比仅依赖药物所接受的审评类型更为有效。
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