Benchmarking the Study Initiation Process
Benchmarking the Study Initiation Process
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DOI：
10.1177/2168479012469947
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发表时间：
2013-01-01
影响因子：
1.5
通讯作者：
Getz, Ken
中科院分区：
文献类型：
--
作者：
Lamberti, Mary Jo;Brothers, Cindy;Getz, Ken
试验的研究启动阶段是制药和生物技术公司关注的一个领域，以减少延迟并提高效率。为了更好地了解和检查研究启动过程中的指标，塔夫茨药物开发研究中心与11家制药和生物技术公司合作，检查了一套全面的指标，并分析了来自105项全球临床试验的研究数据。结果表明，网站启动过程的早期阶段是占大部分周期时间的领域。检查治疗领域的第一个患者的周期时间也显示出差异。到首例患者的周期时间因部位类型和地区而异。学术机构和政府资助的网站是最长的第一个病人，而医生的做法是最快的。
The study start-up phase of a trial is an area that pharmaceutical and biotechnology companies are focusing on in order to reduce delays and improve efficiency. To better understand and examine metrics within study start-up, the Tufts Center for the Study of Drug Development, in collaboration with 11 pharmaceutical and biotechnology companies, examined a comprehensive set of metrics and analyzed study data from 105 global clinical trials. The results indicate that the early stages of the site initiation process are areas that accounted for the majority of cycle time. An examination of cycle time to the first patient in by therapeutic area also reveals variation. Variations in cycle time to the first patient occur by site type as well as by region. Academic institutions and government-funded sites were longest to the first patient in, while physician practices were fastest.