@edyong209 not that that's an excuse for secrecy, of cousre
@statsguyuk @david_colquhoun @edyong209 Medical ethics no longer offer reassurance for me. And that policy seems to rely on self-reporting?
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@C7RKY Well, the policy relies on the drug being licensed, which I guess isn't going to happen here if the drug was responsible for the harm -
@C7RKY Though there will be a legal requirement to submit a report to the French authorities in any case. -
@C7RKY I'm afraid I don't know what the French authorities' policy is on public disclosure -
@statsguyuk Appreciated. Does that legal requirement to report stem from harm caused or just because it's a trial? Hardly watertight, is it? -
@C7RKY Because it's a trial of an investigational medicinal product. Harm is not relevant to reporting requirements -
@statsguyuk Well that's something. Presume any failure to comply with that requirement wouldn't have been noticed tho, as it's unregistered? -
@C7RKY Permission would have been needed from French authorities before trial could start, so they would know about it -
@statsguyuk Interesting. I assume someone's confirmed that they got that permission & it's not something that flows from trial registration? - 3 more replies
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