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  • 1.  Blinding and Unblinding Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 16-May-2022 09:27
    This message was posted by a user wishing to remain anonymous

    Is there any guidance on who should and who should not be blinded in a clinical trial?


  • 2.  RE: Blinding and Unblinding Requirements

    Posted 16-May-2022 14:01
      |   view attached
    To answer that question I feel like we would need to know a lot more about the objectives of the trial, including the intervention.
    ISO 14155:2020 doesn't really touch on blinding save 6.3 Justification of trial design and then only to minimize bias. Attached is a useful publication that introduces some fundamentals.
    Best wishes

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    Steve Baker
    i-SMART Consulting US
    US +1 267 432 1045
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    Attachment(s)

    pdf
    Karanicolas - Blinding who what when how.pdf   432 KB 1 version
    Original Message


  • 3.  RE: Blinding and Unblinding Requirements

    Posted 17-May-2022 07:45
    ICH E6 speaks cryptically about blinding and unblinding:

    "A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s)."

    This is usually interpreted to mean, and general rule of thumb, that anyone who doesn't need to know for the trial to be conducted in a blinded manner should be blinded. For example, anyone at the Sponsor who is in a position to make decisions about conduct of the trial or management of a patient must be blinded. Some people needed to be unblinded, such as the individuals holding the randomization codes if emergency unblinding is necessary for safety reasons, the clinical supplies team members, and pharmacovigilance for determining whether a serious adverse event is reportable. In the end, it depends on the design of the clinical trial and individual decisions need to be made.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 4.  RE: Blinding and Unblinding Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 17-May-2022 10:38
    This message was posted by a user wishing to remain anonymous

    I would suggest you review this guidance from FDA also "Establishment and Operation of Clinical Trial Data Monitoring Committees ". Blinding depends on the phase of the study, the purpose of blinding, etc.
    Original Message


  • 5.  RE: Blinding and Unblinding Requirements

    Posted 17-May-2022 13:24
    Your GCP SOP in This topic should cover this topic.  Additionally, anyone who can be perceived as influencing the outcome of a study should be blinded, outcome meaning safety and efficacy. Another useful guidance is "

    Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for IndustryAUGUST 2019".


     



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    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
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    Original Message


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