Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK

Objective: To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development. Design: Retrospective observational study. Setting and data source: Database of new preparations added annually to the British National Formulary (BNF). Main outcome measures: The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF. Results: There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced ann...

研究目标：描述1982年至2011年英国上市新药的变化趋势，并验证“本研究周期内新药上市速率呈下降趋势”这一假说。当前全球范围内广泛存在制药研发创新能力衰退的担忧，已有报道的趋势显示，尽管近数十年来制药行业研发投入持续攀升，但新药上市数量却有所减少。
研究设计：回顾性观察研究。
研究场景与数据来源：采用英国国家处方集（British National Formulary, BNF）的年度新增制剂数据库。
主要结局指标：以首次收录入英国国家处方集为判定依据，统计每年新增的药物数量，涵盖新化学实体（new chemical entities, NCEs）与新型生物制剂。
研究结果：1982年至2011年间，英国新增上市新药数量未呈现显著的线性变化趋势。1980年代中期出现一次波动低谷（1985年至1987年间，每年新增11至12个新化学实体/生物制剂），此后新药上市数量呈现波动式增长……