@MYTH@bubu, chercheur de cadavres
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.
Bubu12 d’
AvoxTV décide comme ça, un jeudi, que l’essai clinique de Pfizer peut être considéré comme du double aveugle.
Avez-vous essayé de transmettre votre trouvaille au
Big Boss ?
Avant, il faudrait cependant lire attentivement le protocole de Pfizer. Voilà quelques petits extraits :
The study staff receiving, storing, dispensing, preparing and administering the study interventions will be unblinded.
Contact between the unblinded dispenser and study participants and unblinded administrator and study participants should be kept to a minimum.
To facilitate rapid review of data in real time, sponsor staff will be unblinded to study intervention allocation for the participants in Phase 1. The majority of sponsor staff will be blinded to study intervention allocation in Phase 2/3.
An unblinded submission team will be responsible for preparing unblinded analyses and documents to support regulatory activities .
The sponsor study team will be unblinded during Phase 1
In Phase 2/3, the unblinded team supporting the DMC, including an unblinded medical monitor, will review cases of severe Covid-19 as they are received
All analyses conducted on Phase 2/3 data while the study is ongoing will be performed by an unblinded statistical team.
At any point the unblinded team may discuss with the DMC chair wheter the DMC should review cases for an adverse imbalance of cases of Covid-19 and/or severe Covid-19