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Discontinued drugs in 2012: cardiovascular drugs
Hong-Ping Zhao1, Hong-Min Jiang, Bing-Ren Xiang
1China Pharmaceutical University, Ministry of Education, Center for Instrumental Analysis, Key Laboratory of Drug Quality Control & Pharmacovigilance , Nanjing, Jiangsu 210009 , China +86 25 8327 1180 ; +86 25 8327 1335 ; hpzhaojstar@126.com.
Abstract:
The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products.
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