How not to run a single-arm trial: EMA highlights more than a dozen 'biases' — and ways to mitigate them
The European Medicines Agency today outlined some potential biases — and possible solutions — for biopharma companies that wish to submit clinical data from single-arm trials for potential product approvals.
EMA said a reflection paper dated April 17 is now open for public comment, with a focus on the concepts and challenges related to single-arm trials (SATs), as well as to look at options to potentially improve how the trials are designed and run.
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