Project Scope |
Development of R-shiny application(s)an open-source tool and package to enable thegeneration of identifiedof identified interactive plots for clinical review and direct inclusion in submission packages forsubmissions to regulatory agencies. InitialThe initial scope is to develop toolsa package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissionsubmissions to the FDA. This work is in conjunction witha collaboration among the American Statistical Association (ASA), PHUSE and the FDA. |
Project Leads |
|---|
Bryant Chen
Dhananjay Chhatre
Melvin Munsaka
Melvin Munsaka, Abbvie | |
Jiang (Jessica) Hu, FDA | |
| Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
| Kerry Robson, PHUSE Project Assistant |
Key Milestones
| Objective | Timeline |
|---|---|
| Develop and Complete a prototype | Q4 2020 | Develop a R-shiny application | Q4 2020
| Q42020||||||
| Continuing to build prototype | ||||||
Project Members | Organisation | |||||
|---|---|---|---|---|---|---|
Hanming Tu | Frontage Laboratories | |||||
Ivan Zou | Sanofi | |||||
Jeremy Wildfire | Gilead | |||||
Kyle Wathen | Gilead | |||||
Mary Nilsson | Eli Lilly | |||||
Mike Stackhouse | Atorus Research | |||||
| Minchen Wang | Gilead | |||||
Ting Zhang | Sanofi | |||||
| Vaishali Popat | FDA | |||||
Vipin Arora | Eli Lilly | Zachary Skrivanek | Eli Lilly||||
Q1 2024 | ||||||
|
| Objectives & Deliverables | Timelines |
|---|---|
| An open-source R Shiny tool for generating the plots and associated outputs and an accompanying paper for the tool | Q3 2022 |
| Complete manuscript | Q4 2024 |
| Resources |
|---|
| CVARS GitHub Page |
| CVARS |