Project Scope |
Development of R-shiny application(s) an open-source tool and package to enable the generation of identified of identified interactive plots for clinical review and direct inclusion in submission packages for submissions to regulatory agencies. Initial The initial scope is to develop tools a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submission submissions to the FDA. This work is in conjunction with a collaboration among the American Statistical Association (ASA), PHUSE and the FDA. |
Project Leads | |
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Melvin Munsaka |
, Abbvie |
Jiang ( |
Jessica) |
Hu, FDA | |
| Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
| Kerry Robson, PHUSE Project Assistant |
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| Objectives & Deliverables | Timelines | |||||
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| An open-source R Shiny tool for generating the plots and associated outputs and an accompanying paper for the tool | Q32022 | |||||
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· Stage 1 forest plot prototype completed (available @ https://github.com/phuse-org/aesummaries; example @ https://forest-plot.netlify.app/). · Requirements for aesthetic improvement for the forest plot update for the Stage 1 prototype have been finalised. · Requirements for the volcano plot have been finalised. · Draft outline and literature review for the accompanying paper for Stage 1 has been completed and team are now working on the white paper. | ||||||
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 | |||||
| Neetu Sangari | Pfizer | |||||
Ting Zhang | Sanofi | |||||
| Vaishali Popat | FDA | |||||
Vipin Arora | Eli Lilly | Zachary Skrivanek | Eli Lilly||||
| Q3 2022 | ||||||
| Complete manuscript | Q4 2024 |
| Resources |
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| CVARS GitHub Page |
| CVARS |