Project Scope |
Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submissions to regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is 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, Pfizer Pragya Tech Leaders | neetuneetusang@gmail.sangari@pfizer.com |
| Nicola NewtonKerry Robson, PHUSE Project Assistant | nicky@phusekerry@phuse.global |
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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. | Q3 2022 |
| Complete manuscript | Q4 2024 |
| Resources |
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| CVARS GitHub Page |
| CVARS |