如何在中国开展临床试验(二)——一个临床研究者的经验分享

How to Conduct Clinical Trials in China?(Ⅱ)

临床试验进行中的方案执行尤为重要,关乎整个试验的成功与否。临床试验团队应对方案执行中的每一细节力求按计划进行,如发生方案偏倚或违背时,要及时发现并积极处理,尽可能令方案始终按预定的基线进行。另外,试验进行中首先考虑的是患者的安全性,一切以患者为中心。

The implementation of clinical trial protocol is particularly important,which is related to whether the whole clinical trial can succeed or not.Clinical trial team should ensure that any detail in the protocol should be implemented according to the plan,if any bias or violation to the original portal occurs,the protocol should be implemented according to the planned baseline as strict as possible.In addition,safety of the participating patients should be the priority to be considered in clinical trial,and patients should be focused as the center.