Data from: 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 annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period. Conclusions: The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.

研究目的：描述1982年至2011年英国上市新药的变化趋势，并检验本研究周期内新药上市速率呈下降趋势这一假说。当前学界广泛担忧制药创新能力正出现衰退，现有报道的趋势显示，尽管研发投入持续增长，近数十年来上市新药的数量却有所减少。
研究设计：回顾性观察研究。
研究场景与数据来源：采用每年新增入《英国国家处方集（British National Formulary，BNF）》的制剂数据库。
主要结局指标：以首次收录入BNF为依据，统计每年新增的新药数量，包括新化学实体（new chemical entities，NCEs）与新型生物制剂。
研究结果：1982年至2011年间，英国上市新药的数量未呈现显著的线性变化趋势。在20世纪80年代中期出现一次低谷（1985年至1987年间，每年新增11~12个新化学实体/新型生物制剂）后，每年新增新药数量呈波动上升态势，并于1997年达到峰值34个。该峰值后，新药数量有所回落，在2003年至2006年间维持在每年约20个的水平，并于2010年再次出现峰值。结合已发表的公开数据将研究时间轴回溯至更早时段可见，1971年至2011年的完整周期内，新药上市数量整体以每年0.16个的速率小幅增长。
研究结论：所谓的“创新衰退”实为既往研究所选时间区间带来的假象。有关制药创新能力衰退的报道，需结合其研究的时间尺度与视角进行综合研判。