What inspired this Wish List Request?
When aggregating adverse events in JMP Clinical, the default is to create a summary table using the English names of the adverse events in the dataset. However, PMDA requires the use of Japanese adverse event names for review reports. Therefore, it would be desirable to have a feature that allows the creation of summary tables using Japanese names for adverse events.
Please describe the new or improved feature or solution you would like to see.
PMDA receives adverse event datasets in English from sponsors. Currently, they first create a summary table in English and then use an add-in to retrieve the MedDRA dictionary to translate the adverse event names into Japanese. It would be ideal if JMP Clinical had a built-in feature that allowed users to directly create summary tables in Japanese without relying on an add-in.
What would the value be to you and/or other users if this new feature is provided?
If this new feature is implemented, PMDA will no longer need to maintain the add-in after each upgrade of JMP Clinical, reducing the operational burden. Other Japanese users will also benefit by being able to create summary tables in Japanese.
Is this an external customer request?
Yes, this is a request from PMDA. The key contact person is Koichi Ishikawa.
Is there a competitive software package that has this feature or solution that we should be aware of?
Currently, no competitive software has been identified that offers this specific feature.
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
PMDA believes that this feature will motivate staff to use JMP Clinical more. The increase in the number of users would secure the renewal.
Hello @HMY, which version of JMP Clinical does PMDA uses? Which platform in JMP Clinical is used in order to create the summary table. Would it be possible to share the addin to see exactly what the addin is doing? Thank you
PMDA is currently using JMP Clinical 17.2 and plans to migrate to JMP Clinical 18.2 this year. The summary tables generated by PMDA's add-in are considered equivalent to the tables in JMP Clinical's Adverse Events Distribution report, translated into Japanese. However, I think that the add-in operates independently of JMP Clinical and is written in JSL. I will contact you upon receiving information regarding the add-in's details and its shareability from PMDA.
Hi @Valerie_Nedbal, according to Koichi Ishikawa-san, an IT expert from PMDA, the add-in is independent of JMP Clinical reports and is written in JSL. He mentioned that he cannot provide the add-in itself but will check if he can share its main logic with us. I will update you once he provides more information.
