For many years, efforts have been under way across several sectors of the clinical trials enterprise to improve the efficiency and safety of the clinical trials process. These have included international and regional initiatives by regulatory bodies and other organisations to harmonise operating policies and procedures for ethics committees; data monitoring committees; national regulatory frameworks; case report forms; standards for electronic data capture; clinical trial agreements; and training and education of research teams, to name but a few. Such initiatives have not advanced as quickly as one might hope, despite the ongoing efforts. In addition, many of them exist largely within their own silos, each looking at a selected sector of the clinical trials process, mostly from a regional perspective, despite near universal acknowledgement that the clinical trials process has indeed already "gone global".
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