Facey K M, Lewis J A
Licensing Division, Medicines Control Agency, London, U.K.
Stat Med. 1998;17(15-16):1801-9; discussion 1811-2. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1801::aid-sim981>3.0.co;2-l.
The ethical need for interim analyses in long-term trials of life-threatening conditions is well established, but recently there has been increased enthusiasm for the use of interim analyses in other areas of clinical research. Interim analysis is seen as a powerful tool in drug development to help reduce 'time to market' by allowing key decisions to be made earlier on the basis of one or more ongoing clinical trials. However, this goal can only be achieved without serious penalties if interim analyses are properly designed and executed, so that the integrity of the whole drug development programme is maintained. The purpose of this paper is to define procedures for the design and management of clinical trials which involve interim analyses. These procedures are intended to incorporate good clinical and statistical practice, hence maintaining high scientific standards not only of individual trials but also of the overall development programme. Aspects of design, conduct, analysis and dissemination of results are considered, with particular focus on the effective use of data monitoring committees in confirmatory efficacy trials.
在危及生命疾病的长期试验中进行期中分析的伦理必要性已得到充分确立，但最近在临床研究的其他领域，人们对使用期中分析的热情有所增加。期中分析在药物开发中被视为一种强大的工具，通过允许根据一项或多项正在进行的临床试验更早地做出关键决策，有助于缩短“上市时间”。然而，只有在期中分析得到妥善设计和实施的情况下，才能在不产生严重不利影响的情况下实现这一目标，从而维持整个药物开发计划的完整性。本文的目的是确定涉及期中分析的临床试验的设计和管理程序。这些程序旨在纳入良好的临床和统计实践，从而不仅维持单个试验的高科学标准，而且维持整个开发计划的高科学标准。本文考虑了设计、实施、分析和结果传播等方面，特别关注数据监测委员会在确证性疗效试验中的有效使用。
