Van Gijn J, Algra A
Vakgroep Neurologie, Universitair Medisch Centrum, Utrecht.
Ned Tijdschr Geneeskd. 1999 Jul 10;143(28):1477-9.
Clinical trials for testing the efficacy of new drugs in patients are subject to guidelines issued by the European Union ('Good clinical practice'). These guidelines address, in great detail, the relationship between the physician-investigator and the patient, and also that between the sponsoring industry and the physician-investigator (a deplorable exception being the financial arrangement). A major omission is the lack of safeguards for an appropriate and robust design of the study. This applies to the choice of measures of outcome and possible subgroups, interim analyses and stopping rules, entry and management of data, and the final analysis. It is therefore mandatory that the sponsoring industry allows full and early participation by senior clinicians in the design and execution of a clinical trial, through a steering committee.
在患者身上测试新药疗效的临床试验需遵循欧盟发布的指南（“良好临床实践”）。这些指南详细阐述了医师研究者与患者之间的关系，以及申办企业与医师研究者之间的关系（令人遗憾的是，财务安排方面除外）。一个主要的疏漏是缺乏对研究进行适当且稳健设计的保障措施。这适用于结局指标和可能亚组的选择、期中分析和终止规则、数据录入与管理以及最终分析。因此，申办企业必须允许资深临床医生通过指导委员会全面且尽早地参与临床试验的设计与实施。
