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Improvements must be made to the qualification process for biomarkers as primary endpoints in pivotal clinical studies of treatments for the rarest of diseases.
Lessons from the US Biodefense program should inform international efforts to build a medical countermeasure enterprise for emerging infectious diseases.
To upend current barriers to sharing clinical data and insights, we need a framework that not only accounts for choices made by trial participants but also qualifies researchers wishing to access and analyze the data.
Digital medicine offers the possibility of continuous monitoring, behavior modification and personalized interventions at low cost, potentially easing the burden of chronic disease in cost-constrained healthcare systems.