质量,临床试验永恒的主题

Quality:The Eternal Theme of Clinical Trials

医院对临床试验机构的定位不应只是一个管理部门,同时也是一个学科。我国目前伦理委员会的发展和临床研究的发展相比要滞后,在某种程度上已经限制了临床试验的发展。合理有效的临床试验财务管理制度对促进临床试验的健康发展起着重要作用。

The quality of clinical trial is not only concerned with whether new drug can be launched, but also concerned with the lives of patients. The history of clinical trial in China is shorter than that in Europe and the United States, the overall level cannot meet requirement of development of pharmaceutical industry, and the quality of clinical trial needs to be improved further. Clinical trial involves sponsors, regulators, and medical institutions in many ways, multi-pronged approached should be taken to improve quality of clinical trial. Domestic sponsors should improve their own standards; Regulators should give certain guidance to the sponsors while enhancing quality supervision; And as the implementer, medical institutions should play the critical role.