OSTP RFI on Clinical Research Infrastructure and Emergency Clinical Trials

AMIA provided comments to The White House Office of Science and Technology Policy (OSTP) Request for Information on Clinical Research Infrastructure and Emergency Clinical Trials. AMIA commends OSTP for its focus on efforts to protect the public health in cases of national emergency. An established research infrastructure, uniform protocol for the conduct of emergency clinical trials, and responsible data sharing and oversight requirements should be viewed as necessary components of a national preparedness plan. Only with integrated, longitudinal data at the patient level, can we monitor acute events, formulate appropriate interventions for harm prevention and reduction, fairly allocate resources to mitigate effects in a timely way, and track, predict and measure the effectiveness of interventions. The integrity and security of our health data infrastructure and nation should be a priority to support situational awareness and enable coordinated leadership action.