Research Team
Adam Kroetsch, MPP
Adam brings to the Center more than a decade of experience working at the FDA. Most recently, Adam was the deputy director of the FDA’s Office of Program and Strategic Analysis, which serves as an “internal consultancy” for FDA’s drug center, providing management consulting, policy analysis, process improvement, and advanced modeling and analytic methods to improve the center’s policy, decision-making, and operations. In this role, Adam managed analytical studies and major initiatives in a range of topics related to pharmaceutical regulation and drug safety, including studies on the impact of FDA’s drug labels on health outcomes and the use of innovative health IT solutions to address the opioid crisis.
White Paper
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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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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Decision support tools are valuable, but only if consumers understand them and if they are accurate.
— Charlene Wong, MD, MSHP