Kaitin K I, Mattison N, Northington F K, Lasagna L
Center for the Study of Drug Development, Tufts University, Boston, MA 02111.
Clin Pharmacol Ther. 1989 Aug;46(2):121-38. doi: 10.1038/clpt.1989.116.
This report updates previous studies that documented the existence of a significant lag between new drug introductions in the United Kingdom and in the United States. During the 11-year period from 1977 through 1987, the United Kingdom led the United States in the number of first introductions of new drugs (114 versus 41), in average lead time for mutually available drugs (60.7 versus 28.9 months), and in the number of exclusively available drugs (70 versus 54). Analysis by therapeutic category indicated large United Kingdom leads in the introduction of respiratory (5.1 years), cardiovascular (3.2 years), central nervous system (3.2 years), and anti-cancer (2.9 years) agents, and shorter leads for anesthetic and analgesic (2.0 years), gastrointestinal (2.0 years), endocrine (1.4 years), and anti-infective (0.8 years) agents. A comparison of the 5-year period from 1983 through 1987 with the previous 5-year period (1978 through 1982) showed no change in the length of the lag time (1.9 years for each period). These results indicate that the United States continues to lag behind the United Kingdom in the availability of new drugs.
本报告更新了之前的研究,这些研究记录了英国和美国在新药引进方面存在显著滞后。在1977年至1987年的11年期间,英国在新药首次引进数量(114种对41种)、可共同获得药物的平均领先时间(60.7个月对28.9个月)以及独家可用药物数量(70种对54种)方面领先于美国。按治疗类别分析表明,英国在呼吸系统药物(5.1年)、心血管系统药物(3.2年)、中枢神经系统药物(3.2年)和抗癌药物(2.9年)的引进方面领先幅度较大,而在麻醉和镇痛药物(2.0年)、胃肠道药物(2.0年)、内分泌药物(1.4年)和抗感染药物(0.8年)方面领先幅度较小。将1983年至1987年的5年期间与前一个5年期间(1978年至1982年)进行比较,发现滞后时间长度没有变化(每个期间均为1.9年)。这些结果表明,美国在新药可及性方面继续落后于英国。