(Total Views: 1002)
Posted On: 09/18/2017 9:10:55 PM
Post# of 72447
According to Leo's email, most patients have completed the study. I think Leo receives patient reports weekly because the site investigator writes reports weekly. So he probably has seen most of the patient reports (blinded) at week 6.
My guess is that Leo requested to unblind the interim analysis and the site investigator cautioned him about bias because it's too late. The B-OM interim data were on patients who completed the whole treatment, whereas the P interim data were planned for patients who completed half the treatment. He's requesting data at week 6, but it could create an investigator bias because the week 12 data are also available. The investigator can see the final results. If Leo is requesting interim data after week 12, then there might not be an investigator bias.
My guess is that Leo requested to unblind the interim analysis and the site investigator cautioned him about bias because it's too late. The B-OM interim data were on patients who completed the whole treatment, whereas the P interim data were planned for patients who completed half the treatment. He's requesting data at week 6, but it could create an investigator bias because the week 12 data are also available. The investigator can see the final results. If Leo is requesting interim data after week 12, then there might not be an investigator bias.
Quote:
Can it be possible that Leo has only seen 40/50 % of the 6 week data on July 1??
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