Parece que empiezan mitad/final de Noviembre. Las razones aparentemente (de IV):
I had a long talk with one of the managers with the trial site...she was awesome. She reported that it is a protocol change prompting the change in schedule. She said the company wants to do specific training with all the sites before they begin actual trials. In that sense (strictly my opinion) it would seem likely it's a pretty significant change.
I asked if such a delay was unusual...she said, "Not at all. Another company doing a Covid trial has changed their protocol nine (9) times." We also concluded together, that since it was a change requiring first person contact with the company, it likely affected all sites, though she couldn't confidently say that was the case. So, I'll say it, that was the case.
She gave me a great explanation of all that goes into a trial and for anyone who thinks it's simple, it would just prove you don't understand or know much. She also offered that she doubted seriously it had anything to do with anything other than a process or added participants.
One very good point she made is, if a company even changes a single word, all the participants have to come back in and sign a new document that includes that change. So, if the change is significant, it will obviously take time.
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No me parece nada no usual. Lo único que semanas de retraso nos parecen mucho.
Lo "bueno" (para el estudio) es que las zonas de UK donde están haciendo la fase 3 tienen muchos casos (aunque están con lockdowns y eso bajará la transmisión)...
