MITRE’s Response to the OSTP RFI on Clinical Research Infrastructure and Emergency Clinical Trials

What’s the issue? The White House is “leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies. Efforts in this area could include the establishment of a U.S.-level governance structure and outreach to a wide range of institutions, clinical trial networks, and other potential trial sites that can participate in emergency research, both domestically and internationally.” They requested input, via Request for Information, on a number of matters to support this work.

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. Collaboration and coordination across multiple public agencies and private entities is needed to create a holistic strategy to map efforts so that duplications and gaps can be identified and addressed.

The first step in designing an effective governance structure for this activity is to recognize that it will predominantly be a voluntary collaboration spanning a wide range of entities, each with varying levels of commitment and resources. We recommend leveraging a construct that has been successful in similar situations that consists of three components:

• A federal government role to leverage resources, data, and the varied opportunities for piloting ideas that are distributed throughout the government.
• A private sector network of networks to bring together and leverage private sector expertise and resources from throughout industry, academia, research organizations, and non-profits (and in this case, various healthcare-specific entities).
• An “operator” entity to serve as both a strategic and tactical coordinator and as a trusted third party between the government and private sectors.