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What's the definition of observer-blind study during vaccination trials?

 
McKracken

User ID: 77750652
United States
01/22/2022 11:14 PM
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What's the definition of observer-blind study during vaccination trials?
Does observer-blind mean, the patient may know/decide if they get/want the placebo (saline)? Or what's the difference compared to the more often used term double-blind?

quoting [link to www.nejm.org (secure)]

This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. sites. Participants received the first trial injection between July 27 and October 23, 2020.

The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group).

The Coronavirus Efficacy (COVE) phase 3 trial was launched in late July 2020 to assess the safety and efficacy of the mRNA-1273 vaccine in preventing SARS-CoV-2 infection.

McKracken  (OP)

User ID: 77750652
United States
01/25/2022 12:10 AM
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Re: What's the definition of observer-blind study during vaccination trials?
In this document of a similar study, the same term is used and explained in more detail. Question solved:

quoting [link to cdn.pfizer.com (secure)]

In this observer blinded study, the study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded.

All other study and site personnel, including the investigator, investigator staff, and participants, will be blinded to study intervention assignments.

Because the BNT162 RNA-based COVID-19 vaccine candidates and placebo are different in physical appearance, the study intervention syringes will be administered in a manner that prevents the study participants from identifying the study intervention type based on its appearance.

The responsibility of the unblinded dispenser and administrator must be assigned to an individual or individuals who will not participate in the evaluation of any study participants.
Anonymous Coward
User ID: 79499234
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01/25/2022 12:27 AM
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Re: What's the definition of observer-blind study during vaccination trials?
In this document of a similar study, the same term is used and explained in more detail. Question solved:

quoting [link to cdn.pfizer.com (secure)]

In this observer blinded study, the study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded.

All other study and site personnel, including the investigator, investigator staff, and participants, will be blinded to study intervention assignments.

Because the BNT162 RNA-based COVID-19 vaccine candidates and placebo are different in physical appearance, the study intervention syringes will be administered in a manner that prevents the study participants from identifying the study intervention type based on its appearance.

The responsibility of the unblinded dispenser and administrator must be assigned to an individual or individuals who will not participate in the evaluation of any study participants.

 Quoting: McKracken


That is interesting because they are basically saying that the deathvaxx is appreciably different looking than something like saline (or whatever)?

Or that the saline couldn't be reasonably modified to appear like the deathvaxx? (after developing mRNA nanoparticles they can't figure out how to add coloring etc???)

Or that a scheme couldn't be made to always have two equally large sized groups of administrators always give one or the other and be isolated from one another?

Sounds like more pfizer shenanigans like when they completely unblinded the study after a few months and let the unvaxxed go and take real vaxxes so that no long term control group was left.
Anonymous Coward
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Sweden
01/25/2022 12:49 AM
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Re: What's the definition of observer-blind study during vaccination trials?
Cov, the final frontier.
McKracken  (OP)

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01/25/2022 01:45 AM
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Re: What's the definition of observer-blind study during vaccination trials?
That is interesting because they are basically saying that the [...]vaxx is appreciably different looking than something like saline (or whatever)?
 Quoting: Anonymous Coward 79499234


Yes, that's my interpretation: Either because of different vials or because of difference in colors of the liquid. The dispenser or administrator, i.e. the person filling the syringe from the vial would technically be able to distinguish between them.

Unfortunately they don't specify clearer why the injection dispenser cannot be blinded.

Last Edited by McKracken on 01/25/2022 01:48 AM
Anonymous Coward
User ID: 79499234
United States
01/25/2022 02:07 AM
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Re: What's the definition of observer-blind study during vaccination trials?
That is interesting because they are basically saying that the [...]vaxx is appreciably different looking than something like saline (or whatever)?
 Quoting: Anonymous Coward 79499234


Yes, that's my interpretation: Either because of different vials or because of difference in colors of the liquid. The dispenser or administrator, i.e. the person filling the syringe from the vial would technically be able to distinguish between them.

Unfortunately they don't specify clearer why the injection dispenser cannot be blinded.
 Quoting: McKracken


I'll bet they can't.





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