TT, good points. A couple of observations / musings about a confirmatory study.
1. It would have quick recruitment (should take a day or three to get significant numbers and PCR test results to confirm are similarly quick). In essence this is a very easy study that would be cheap and quick.
2. Sites are already set up to do the study. Extension of ethics etc is a much easier path than starting from scratch. US data collection site for FDA already in place from the current data collection.
3. All the Australian Dx studies so far published showed insignificant difference between the training set results and those obtained in the subsequent double blind confirmatory studies. A good sign but not conclusive of course.
4. There is a gold standard test (PCR) to test the algorithm against, thus eliminating any clinician subjectiveness (which was the problem with the Dx US study).
Looking forward to the announcement.
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