Reichert Janice M, Wenger Julia B
Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, United States.
Drug Discov Today. 2008 Jan;13(1-2):30-7. doi: 10.1016/j.drudis.2007.09.003. Epub 2007 Oct 18.
Global commercial development of cancer treatments has dramatically increased over the past 15 years. To assess trends in the process, we analyzed data for 1111 candidates that entered clinical study during 1990-2006. Our results show that although the average number of therapeutic candidates entering clinical study per year more than doubled, the US approval success rate was low (8%) during the period. The therapeutics took seven years on average to go through the clinical and US approval phases, but cancer vaccines have yet to gain any US approvals. These results indicate that improvement in the efficiency of the development process for innovative cancer treatments is needed.
在过去15年中,癌症治疗的全球商业发展显著增加。为了评估这一过程中的趋势,我们分析了1990年至2006年期间进入临床研究的1111种候选药物的数据。我们的结果表明,尽管每年进入临床研究的治疗性候选药物的平均数量增加了一倍多,但在此期间美国的批准成功率较低(8%)。这些治疗药物平均需要七年时间才能完成临床和美国批准阶段,但癌症疫苗尚未获得任何美国批准。这些结果表明,需要提高创新癌症治疗开发过程的效率。