Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets
FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of data sets was key for FDA in selecting the the partnership, which grew from Reagan-Udall Foundation and Friends of Cancer Research's Evidence Accelerator project.
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US FDA hopes COVID-19 may finally spur data coding changes that will make real-world evidence projects proceed faster. The pandemic is now part of five real-world data projects using FDA's Sentinel system, but some other real-world data projects are paused due to the health crisis. The private sector is also changing the way it conducts real-world data work due to COVID-19.
Agency is going outside its ‘comfort zone’ to leverage different streams of existing real-world data sources to quickly assess the impact of potential treatment approaches, Amy Abernethy says; pandemic experience could lead to a more open embrace of RWE beyond the current public health emergency.