White Paper
A Roadmap for Developing Study Endpoints in Real-World Settings
Kerra Mercon, Nirosha Mahendraratnam, Joy Eckert, Christina Silcox, Morgan Romine, Kathryn Lallinger, Adam Kroetsch, Huzyfa Fazili, Marta Wosińska, Mark McClellan
2020
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Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Nirosha Mahendraratnam, Kerra Mercon, Joy Eckert, Morgan Romine, Adam Kroetsch, Katherine Frank, Rachel Sherman Gregory Daniel, Mark McClellan
2019
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Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Nirosha Mahendraratnam, Joy Eckert, Kerra Mercon, Katherine Frank, Morgan Romine, Adam Kroetsch, Rachel Sherman, Gregory Daniel, Mark McClellan
2019
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Determining Real-World Data’s Fitness for Use and the Role of Reliability
Nirosha Mahendraratnam, Christina Silcox, Kerra Mercon, Adam Kroetsch, Morgan Romine, Nicholas R. Harrison, Adam Aten, Rachel Sherman, Gregory Daniel, Mark McClellan
2019
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Decision support tools are valuable, but only if consumers understand them and if they are accurate.
— Charlene Wong, MD, MSHP