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Ann: Pre-Submission package lodged with the US FDA, page-28

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AlCp

27,364 Posts.

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10/02/21

12:09

Post #: 50856334
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Originally posted by Southoz ↑

AICp - page 4 of the protocol paper - in the section on statistical considerations.

The adjudication rates between the Aussie and US doctors were roughly equivalent. The reason for the slight difference will be due to study implementation.

In the Australian studies the researchers are the clinicians in the hospital and have the leverage (and care factor) to ensure high quality information is collected during the study period.

In the US there is a strict separation between clinical and research functions. And the researchers have little ability to influence the quality of information that clinicians produce in routine practice.

Poorer quality information will produce lower rates of adjudication agreement.

I appreciate AICp that as layperson this stuff is not simple to understand. But posting prolifically doesn't actually make you know anything better.

Expand

Hence my point that 33% of the disagreement had a factor of the accuracy in the US clinical trial compared to that done in Australia, can you provide the link to that paper, this accuracy wasn't mentioned in the primary outcome of the clinical trial.

Last edited by AlCp: 10/02/21

RAP Price at posting: 7.0¢ Sentiment: Buy Disclosure: Held
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