JOHNS HOPKINS UNIVERSITY, THE

The Partnership in Applied Comparative Effectiveness Science (PACES) is an initiative that seeks to advance the science for comparative effectiveness research by leveraging available clinical trial data held by the Food and Drug Administration (FDA). The PACES initiative is a collaboration between the FDA and Johns Hopkins University. Johns Hopkins investigators will work with the FDA?s scientific and statistical experts to define questions, identify datasets, and select the optimal approaches for analyses using the FDA data and other large external datasets to answer questions about effectiveness. Additionally, Johns Hopkins will participate in at least three FDA-hosted scientific workshops that address issues related to the methods for comparative analyses, best practices in comparative effectiveness research, and novel approaches to understand the effectiveness and safety of medications, devices, and biological products. Johns Hopkins will provide scientific training to benefit future FDA-comparative effectiveness efforts and enhance the expertise of their scientists in using trial data. This collaboration will result in the generation of reports to convey scientific approaches used for comparative effectiveness studies and the publication of manuscripts with FDA and Hopkins authorship. Additionally, the Johns Hopkins investigators aim to produce tools, such as programming code, that may be used by the FDA for evaluation of other product submissions. Johns Hopkins has three subcontractors on this project: the Lewin Group, the Center for Medical Technology Policy, and Buccaneer Computer Systems and Services, Inc. Each of the subcontractors brings unique skills and resources to the PACES initiative.

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