RWE: Comparators, Therapeutic Area May Be Key For Trial Replication
It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.
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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.
Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.