Akari Kamiya, Assistant Manager, Analysis Center, Shionogi & Co., Ltd.
Yoshitake Kitanishi, Group Leader, Analysis Center, Shionogi & Co., Ltd.
JMP Clinical is a useful tool for data review. However, it is difficult to master it. As it is a tool used by the FDA/PMDA, many organizations would like to master it, but it is a waste of its value.
Hurdles include:
1. Loading data
2. Reviewing the data (performing analysis)
3. Interpretation of Results
4. Standardization and organization building
Examples include:
Once this hurdle is overcome, JMP Clinical can be used as a tool to discover irregular data, identify facilities requiring caution, and confirm safety during the study. At the end of the study or before application, pharmaceutical companies can check the clinical trial data from a similar perspective, assuming that the PMDA/FDA will review the data using JMP Clinical.
If users can use JMP Clinical effectively, they will be able to gain a lot of knowledge. In Japan, there are few reports of JMP Clinical usage. In this presentation, I would like to introduce some examples and exchange opinions with the participants. As a result, I hope to use JMP Clinical more effectively.
