Could reports for efficacy endpoints be standardized?

yupnglee

In JMP Clinical 8, we already have templates about efficacy for oncology studies.

Some clients are curious about if there would be more efficacy templates(for other therapy areas) adding to our JMP Clinical and their questions provoke my thoughts.

In my view, it means various efficacy analyses for different therapy areas should be standardized like those safety analyses. But can efficacy analysis (templates/reports) really be standardized? For example, in Atopic Dermatitis studies, many endpoints like EASI/IGA/PtGA/DLQI... will be used and the statistical methods vary in different studies.  

I would like to hear your guys' ideas about this topic.:smiling_face_with_smiling_eyes:

Chris_Kirchberg

Hi @yupnglee ,

 

When we released the Tumor Response report and showed customers this report, they became excited and asked many of the same questions that you have. Adding a standardized Clinical Endpoint Response report that is similar in nature to the Tumor Response report is something that has been added to the feature enhancement list for a future version of JMP Clinical.  In the mean time, we need to collect as many customer names (company names) and specific details of what they would like to see (links to papers or examples are most helpful).

 

Could you send a list of customers who have asked for this?

 

Also, there are two places for enhancements to be entered: External Wish List for customers and Internal Wish List for staff. Entering ideas and enhancements in these places (along with customer names for internal list) will help us vote and prioritize, 

 

We do have some reports like Time Trends and Waterfall Plots (% Change from baseline for both)  that can be used for efficacy if their endpoints are Findings based data. Combining them like in Tumor Response, is one of our goals.  One thing to help make this existing reports more useful is to have a surrogate measure to help determine efficacy like RECIST 1.1 Best Response type criteria.

 

Another idea is to use things like Findings ANOVA for statistical testing of efficacy between treatments. Also Findings Time to Event where the event is defined as some clinical endpoint in time. There are other ways to determine if there is a significant or clinically meaningful event and we would like to hear more about these methods.

 

One can always use the JMP component of JMP Clinical to make their own custom analyses and save as an Add-in.  There is even a set of APIs where one can modify an existing JMP Clinical report in an ad hoc fashion. This was briefly covered in a 2019 Discovery Summit Europe Presentation (look towards the end of the slides). I know you have asked for more documentation on customization and examples so that customers can do it themselves, but unfortunately we only have the API links for a description of the functions.

 

I have begun the process of making some more examples of the use of these APIs but I will leave it to a blog post (or several) to begin the documentation of examples. I hope this will help act as an intermediate solution as we add those reports that are most commonly requested.