Regulatory Open Forum

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  • 1.  Investigator Brochure

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2019 09:11
    This message was posted by a user wishing to remain anonymous

    What training or advice should be given a team regarding IB updating of clinical safety information from ongoing blinded clinical trials vs completed studies?

  • 2.  RE: Investigator Brochure

    Posted 31-Jul-2019 08:24
    I don't think there is a single, correct answer to your question. Since the IB is meant to advise investigators on the safety information they should know to be able to make benefit-risk decisions and medical management decisions for the study subjects, the question is whether the information from the blinded clinical trial will provide appropriate information to assist them in those decisions. My general opinion is that only final data should be in the IB to avoid the problem of misinformation based on draft data. So, including information from a blinded study has even greater chance of providing misleading information. I could hypothesize some specific situations where communicating information from a blinded study might be useful and important. The best case could be if a Data Monitoring Committee identified a specific event that raised a specific safety question. Without un-blinding the study to the rest of the world, that information would obviously need to be included in the IB.

    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States