On May 19, 2021, LEAPS hosted a virtual Design Lab on behalf of MIT Lincoln Labs, DTRA (the Defense Threat Reduction Agency), and its DOMANE (Discovery of Medical countermeasures Against Novel Entities) project. The focus of this event was to begin designing a next-generation outcomes tracking capability that would support warfighter effectiveness in the face of emerging biothreats using COVID-19, and specifically post-acute sequelae of COVID-19 (PASC), as a use case. This Design Lab engaged multi-stakeholder change agents from across the biomedical value chain, including some with prior military experience, in the participatory design of this novel real-world evidence (RWE) generation platform.  

Design sessions centered around the challenges of generating high quality, actionable RWE in the face of imperfect and fragmented data, where uncertainties about both the disease and drug therapies threaten lives, public health, and national security.

Emerging design features of this outcomes tracking capability includes:

• Federated evidence production involving the sharing of evidence rather than data
• A network of partner organizations, each with access to data and advanced analytic capabilities
• Focus on reducing uncertainties associated with both real-world effectiveness of drug therapies as well as the natural history of COVID and PASC
• Empowering the advancement from tracking, to predicting, outcomes

The evolving platform concept will be discussed at the upcoming invitational LEAPS Design Lab (June 10 & 11), including exploration of potential next steps in prototyping, piloting, and scale up.