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MITRE’s Response to the OSTP RFI on Data Collection for Emergency Clinical Trials and Interoperability Pilot

MITRE’s data-driven responses to a White House inquiry requesting input into emergency clinical trials data collection and management.

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What’s the issue? The White House is preparing to “further prepare the U.S. clinical trials enterprise to carry out coordinated, potentially large-scale research protocols in an emergency setting.”  They requested input, via Request for Information, on how best to operationalize protocol distribution and data capture from a technical perspective.

What did we do? The Center for Data-Driven Policy led a cross-MITRE analysis of OSTP’s posed questions, seeking to uncover data and evidence (from our work in the public interest) that would help the White House understand opportunities and develop plans that are evidence-based, actionable, and effective.

What did we find? MITRE’s recommended approach for emergency clinical trials is a system for routine clinical trials that is regularly exercised, routinely improved upon, and available for emergency use when needed. The network should be a pragmatic one, comprised of data available as a consequence of routine clinical care and shared via a common data model.  Patients should be allowed to conduct operations on their own data, and the network should have provisions for research on both deidentified and identified data.