药物临床试验中受试者的依从性管理

药物临床试验是确定药物疗效和安全性的重要方法。药物临床试验是指在人体（患者或健康志愿者等受试者）中进行的关于新药效应的一系列临床实验性研究，以证实或揭示试验用药的疗效和不良反应。受试者依从性可定义为按照规定的药物剂量和疗程服用试验药物的程度。在药物临床实验中，受试者的依从性与试验结果的质量密切相关：受试者不依从或依从性差是导致影响实验结果，造成偏倚的关键因素。此外，提高依从性还可以节约时间、经费，缩小实验规模。加强依从性管理，提高受试者依从已引起越来越广泛的重视。然而，目前我国在新药临床实验中，影响依从性的因素普遍存在，也没有一种足够可靠、有效、敏感的测量依从性的金标准，并缺乏客观评价受试者依从性的有效工具。因此，药物临床试验受试者的依从性管理已成为当代医学界亟待解决的重要课题。本文就依从性的影响因素、依从性的评价方法、管理措施做出如下探讨。以期在药物临床试验中，为提高受试者依从性提供理论和实践依据。

Compliance Management of the Subjects in Clinical Drug Trials

The clinical drug trial is an important method to assure the effect and security of drug,which means that to confirm or reveal test drugs'efficacy and adverse reactions,the researchers conduct a series of clinical trials about new drug effect in human(patients or healthy volunteers).The compliance of subjects can be defined as the level of drug taken according to the required drug dose and the period of treatment.In the clinical drug trial,the compliance of the subjects is closely related to the quality of the trial results:The bias of the result from the clinical drug trial is always caused by the noncompliance or poor compliance of the subjects.Additionally,improvement of compli- ance could save time and funding and lead to reduction of trial scale.So,it has become increasingly important to intensify the management of the compliance and improve the compliance of the subjects.However,the factors af- fecting the compliance of the subjects exists widely,there also have no enough reliable,effective and sensitive standards measuring the compliance of the subjects and the effective tools for assessment of compliance are lacked until nowadays in china.Therefore,the compliance management of the subjects in clinical drug trial has become an issue to be resolved in the contemporary medical world.Those have been discussed that the affected factors,the e- valuation methods and the managing ways about the compliance of the subjects in clinical drug trial,which will sup- ply theoretical and practical basis for improving compliance.