JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission

Question

See how to:

* Understand benefits of using JMP Clinical to generate patient narratives
* Customize Narratives Using Templates* Register a study
* Explore and select subjects for narratives
* Select Adverse Event narrative template
* Specify information to include in narratives (event types, exposures, concomitant medications and medical history)
* Select findings to include in narratives
* Examine narratives
* Save narratives as MS Word files

* Generate Graphical Patient Profiles* Examine and interpret graphical and tabular patient results
* Copy graphs and tables to narratives
* Export tables to MS Word
* Customize, select and reorder graphical information
* Save customized graphical format to Patient Profile template for reuse

NOTE: Q&A included at 28:40.

Resources

* JMP Partners who might provide JMP Clinical services, including generating templates

Patient_Narratives_JMP_C_2021.pptx

Chris_Kirchberg · Answer

@PatrickGiuliano ,

There is not a specific capability within JMP or JMP Pro that can replicate what JMP Clinical does for creating Patient Narratives except for exporting a Journal or Report in RTF which can be opened in Word.

JMP Clinical uses a combination of Velocity Template Language (VTL), Rich Text Format (RTF), JSL, SAS and Java to be able to generate the tables need to feed into a template that is a combination of VTL and RTF that is then invoked by Java. The SAS part could be completely replaced by JSL and I supposed it could also replace the VTL component.  RTF files can be read by Microsoft Word and JSL would need to be written to use the formatting language to export a document/file so it could be read in programs like Microsoft Word.. There are other formats as well like OpenDocument (ODT/ODT) and I see that Office 365 can read ODT files. JSL would have to be written to create these XML based files.

With that said, I am sure one could find a way (with heavy scripting in JSL), to extract content from JMP reports, insert it into a template like framework (which could be its own file, much like what JMP Clinical does), incorporate user input, and then export as an RTF file. It would be a lot of work.

gail_massari · Answer

@ron_horne  Here is a page with some resources.  I noticed that one is a broken link to some stability analysis info., and I am looking into that

https://www.jmp.com/en_us/support/jmp-resources-for-pharma-biotech-industries.html

Also, this book by Rob Lievense might be of interest:

https://support.sas.com/content/dam/SAS/support/en/books/pharmaceutical-quality-by-design-using-jmp/70178_excerpt.pdf

gail_massari · Answer

@Chris_Kirchberg and @Byron_JMP , @ron_horne had a question you may be able to answer:

I am looking for a drug synergism analysis in JMP but couldn't fine any. would you be able to point me to anything on the topic? otherwise, an example in sas may also be useful.

I did see the dose response analysis example in the following link  which is part of the topic: More choices for modeling nonlinear responses