Jongen P J
European Charcot Foundation, Institute for Neurology, University Hospital Nijmegen, The Netherlands.
Mult Scler. 1995;1 Suppl 1:S60-3.
Data handling is a crucial phase in controlled clinical trials. In this paper we conceive the process of data handling in a broad sense, encompassing monitoring, analysis and publication of data. We discuss basic ethical principles underlying adequate data handling and suggest some modifications of the Good Clinical Practice guidelines. As to data monitoring, we underline the corporate responsibilities and argue in favour of an independent Data and Safety Monitoring Board (DSMB). Data analysis should be performed in independent institutions, and there is a moral obligation to perform an interim analysis. Regarding accessibility of data, the raw data should be made available to participating researchers and independent scientific institutions, and both positive and negative results should be published, in agreement with a Report on Drug Information by the World Health Organization. To meet these requirements, commercial sponsors should have initiatives for independent DSMBs, interim analysis and complete data availability, and conceive corresponding contracts. The investigators can improve the quality of data handling by forming an Investigators Liaison Panel that represents them in the contacts with the sponsor. Finally, ethics committee and drug regulatory agencies should see to it that newly gained insights are being put into practice.
数据处理是对照临床试验中的一个关键阶段。在本文中，我们从广义上构想数据处理过程，包括数据监测、分析和发表。我们讨论了充分数据处理背后的基本伦理原则，并对《药物临床试验质量管理规范》指南提出了一些修改建议。关于数据监测，我们强调企业责任，并主张设立独立的数据与安全监测委员会（DSMB）。数据分析应在独立机构进行，并且有进行期中分析的道德义务。关于数据的可获取性，原始数据应提供给参与研究的人员和独立科研机构，并且应按照世界卫生组织的一份药物信息报告的要求，同时发表阳性和阴性结果。为满足这些要求，商业申办者应主动设立独立的DSMB、进行期中分析并实现数据的完全可获取性，并拟定相应合同。研究者可以通过组建一个在与申办者的联系中代表他们的研究者联络小组来提高数据处理质量。最后，伦理委员会和药品监管机构应确保新获得的见解得到落实。
