All the comments about randomised trials are fair. Yes, you can (and probably should) do them in this population. Although to be fair the role for much radiotherapy is a bit light for evidence. Yes they will need to be done for FDA. Yes clinicians will want to see some done. Journals want randomised trials to publish.
But I have asked the CEO directly - twice - whether or not a randomised trial of any kind was specified, requested or expected for CE approval process.
The answer both times was an emphatic no.
All the comments about randomised trials are fair. Yes, you can...
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