Calder N, Boyce M, Posner J, Sciberras D
Clinical Pharmacology, Merck Sharp and Dohme, Harlow, UK.
Br J Clin Pharmacol. 2004 Jan;57(1):76-9. doi: 10.1046/j.1365-2125.2003.01961.x.
This study, conducted by the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI), was designed to determine the amount of Phase 1 activity in the UK in the period 1999-2000, the timelines involved for submissions to ethics committee and responses from ethics committees.
A questionnaire was completed by AHIPPI members from pharmaceutical companies with in-house phase 1 units, by Clinical Research Organizations (CRO's) and by academic centres. A few responses were also vailable from organisations that were not AHPPI members. Results were rendered anonymous and grouped by category.
The response rate was > 98% and indicated that the vast majority of early drug research in humans is now CRO-based (82%). The total number of studies (as indicated by protocol numbers) was notably similar across the 2 years--629 in 1999 and 606 in 2000. Turnaround time for ethics committee review was a mean of 14 days.
These data set important benchmarks for early-phase drug research in the UK where regulatory approval is not currently required. Furthermore, the information should be used as a guide if the competitive nature of such work in the UK is to be maintained as new national legislation is implemented following publication of the European Union (EU) Clinical Trials Directive.
本研究由制药行业人类药理学协会（AHPPI）开展，旨在确定1999 - 2000年期间英国一期临床试验的活动量、提交伦理委员会审批的时间线以及伦理委员会的回复时间。
制药公司内部设有一期临床试验部门的AHPPI成员、临床研究组织（CRO）以及学术中心完成了一份调查问卷。一些非AHPPI成员组织也提供了回复。结果进行了匿名处理并按类别分组。
回复率超过98%，表明目前绝大多数人体早期药物研究以CRO为基础（82%）。这两年的研究总数（以方案编号表示）显著相似——1999年为629项，2000年为606项。伦理委员会审查的周转时间平均为14天。
这些数据为英国早期药物研究设定了重要基准，目前在英国该阶段无需监管批准。此外，如果要在欧盟临床试验指令发布后新的国家立法实施的情况下保持英国此类工作的竞争力，这些信息应作为指导。
