The US FDA does not appear ready to add indications to drug labels solely based on real-world evidence, even if the correlations to clinical trial data are strong, but still wants the experiments to be done.
Ultimately, the more attempts at making the leap that are seen, the easier it will be for FDA to write guidance and determine best practices, so down the road real-world...
One step towards building supporting data came from a pilot project initiated by the Friends of Cancer Research. FOCR convened six data partners to determine whether real-world evidence can be...