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loanranger

04/15/21 8:48 AM

#355707 RE: Michel #355688

"are we clear where we are?"

I think your links cleared things up a lot. Thanks.




From https://www.ncbi.nlm.nih.gov/books/NBK546641/
"A double-blind study blinds both the subjects as well as the researchers to the treatment allocation. Triple-blinding involves withholding this information from the patients, researchers, as well as data analysts."

From https://mailchi.mp/ipharminc/innovation-pharma-completes-interim-safety-data-reviewdmc-approves-increased-dosing-frequency-in-phase-2-clinical-trial?e=0e1a610318
"an independent Data Monitoring Committee (DMC) completed its scheduled review of interim safety data in the Company’s randomized, double-blind, placebo-controlled Phase 2 clinical trial"
"Efficacy data was not reviewed by the DMC and remains blinded."


The first link also says this:
"Unblinding may occur during any portion of the blinded clinical trial. Unblinding that occurs before the conclusion of a trial may be a source of bias that the study should document and report. It is the responsibility of all the healthcare professionals involved in a clinical trial, such as physicians, nurses, pharmacists, technicians, and data analysts, to maintain blinding as effectively as possible during the trial and to report any premature unblinding."