Dupin-Spriet T, Spriet A
Therapie. 1991 Jan-Feb;46(1):69-74.
On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels).
在全球范围内，临床试验中的药物研发流程总体上朝着质量敏感度更高的方向改进。实现这一目标的方法体现在药品生产质量管理规范（GMP）和药物临床试验质量管理规范（GCP）的交叉领域。这些方法主要有两类，此处给出一些示例：加强控制（通过“评审团”对双盲比较中试验药物的相似性进行核查以及药物追踪的计算机化系统），提高“研究现场的治疗依从性”（使用更具“智能”的药品包装和标签）。
