@MYTH@bubu, et les 12 cadavres
que voyez vous à la ligne "masking" ? réponse : Triiple Participant, Care Provider, Investigator
Mais que voyez-vous dans le protocole de Pfizer ???
C’est sur que c’est plus difficile de lire 140 pages que 6 mots sur une page web, mais il y a quelques informations intéressantes :
An external data monitoring committee (DMC) will be formed and will review cumulative unblinded data throughout the study.
a DMC will conduct unblinded reviews on a regular basis throughout the trial
sponsor staff will be unblinded to vaccine allocation
analyzed by the unblinded statistical team
The following sponsor stafff will be unblinded in Phase 2/3
Those study team members who are involved in ensuring that protocol requirements for study intervention preparation, handling, allocation, and administration are fulfilled at the site will be unblinded for the duration of the study
Unblinded clinician(s), who are not direct members of the study team and will not participate in any other study-related activities, will review unblinded protocol deviations.
An unblinded team supporting interactions with, and analyses for, the DMC
An unblinded submissions team will be responsible for preparing unblinded analyses and documents to support regulatory activities that may be required while the study is ongoing.
the sponsor will conduct unblinded reviews of the data during the course of the study
the unblinded team supporting the DMC, including an unblinded medical monitor, will review cases of severe COVID-19
the unblinded team may discuss with the DMC chair
Qu’est-ce qu’il écrivait
bubu12 dans son message ?!
Dans cet essai, le patient ne sais pas ce qu’il reçoit, celui qui injecte sait (et il ne fait rien d’autre dans l’essai clinique), ceux qui évaluent les effets secondaires et tous le reste du personnel médical de l’essai ne savent pas non plus. L’essai peut donc être considéré comme du double aveugle.
Mais ce n’est pas du tout ce qui est écrit dans le protocole !? MYTHObubu12
serait encore une fois en train de mentir ?