Real-World Evidence: US FDA Framework Emphasizes Data Fitness And Study Quality
Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.
You may also be interested in...
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.
A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.
Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.