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Re: MinnieM post# 347221

Thursday, 02/18/2021 9:53:55 PM

Thursday, February 18, 2021 9:53:55 PM

Post# of 402882
“When is clinical trial considered to be started?”

Generally, a clinical trial begins at recruitment, but the definitive start varies depending on trial design. In the case of B, the trial would have started with clearance to recruit the first patient in ICU, ER, or elsewhere in a hospital setting. So, the start of the trial might be the same day as the final walk-through and final staff checklist/training for procedure according to protocol. That would all have happened on Dec 17, according to the board discussion these past 24 hours.

But, also, one must keep in mind differences between US and Russian systems for drug approval. The start of the trial would be under stricter guidelines in the US. This would easily account for a one month delay to January. However, the start of the trial would be under similar criteria, and begin at the first recruitment.


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