I thought the consensus was that the trial sponsor
Post# of 72447
(Total Views: 207)
Posted On: 08/15/2017 6:10:33 PM
I thought the consensus was that the trial sponsor has access to the patient profile updates which includes blinded data. In other words they can see what is going on with every patient but do not know which one is getting which arm of treatment.
https://firstclinical.com/fda-gcp/?show=2013/...t=fulllist
https://clinicaltrials.gov/ct2/about-studies/...nd-masking
The protocol on clinicaltrials.gov on the P2B shows masking of the investigator, care giver and patient. It says nothing about the sponsor so I believe they may have access to everything. At a minimum they have the blinded patient profiles which includes adverse effects and the raw data. Those PASI75s and PASI90s will stick out like a sore thumb.
Go IPIX!
https://firstclinical.com/fda-gcp/?show=2013/...t=fulllist
https://clinicaltrials.gov/ct2/about-studies/...nd-masking
The protocol on clinicaltrials.gov on the P2B shows masking of the investigator, care giver and patient. It says nothing about the sponsor so I believe they may have access to everything. At a minimum they have the blinded patient profiles which includes adverse effects and the raw data. Those PASI75s and PASI90s will stick out like a sore thumb.
Go IPIX!
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All my posts are my own personal opinion and speculation. They should not be used as the basis for any investment decision. No, I am not Scottsmith.