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Project Scope |
Development of |
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an open-source tool and package to enable |
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generation of identified interactive plots for clinical review and direct inclusion in |
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submissions to regulatory agencies. |
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The initial scope is to develop |
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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 |
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a collaboration among the American Statistical Association (ASA), PHUSE and the FDA. |
Project Leads |
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Bryant Chen - bryant.chen@fda.hhs.gov
Dhananjay Chhatre - dhananjay.chhatre@gilead.com
Melvin Munsaka - melvin.munsaka@abbvie.com
Melvin Munsaka, AbbVie | |
Jiang (Jessica) Hu, FDA | |
| Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
| Alex Pearce, 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 | Q3 2022 |
| Complete manuscript | Q4 2024 |
| Resources |
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| CVARS GitHub Page |
| CVARS |