Regulatory Open Forum

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  • 1.  Blinded Extension Studies

    This message was posted by a user wishing to remain anonymous
    Posted 03-Sep-2018 16:07
    This message was posted by a user wishing to remain anonymous

    Dear Experts-

    I have been away from Regulatory Affairs for awhile to take care of my aging parents.  I am trying to refresh myself with the regulations and new guidance and becoming familiar with trail designs.  I have noticed that Clintrial.gov has many long-term extension studies blinded with placebo and/or active comparator.  Why?  When I was previously in Regulatory Affairs these studies were always uncontrolled.  Has the requirements changed?

    Appreciate any insight that you can provide.

    Thanks!


  • 2.  RE: Blinded Extension Studies

    Posted 04-Sep-2018 09:09
    Welcome back.

    You recollection is correct, in general, but there could be a number of strategic reasons to continue a long-term extension blinded.  What first comes to mind would be when you needed to collect longer-term clinical outcomes that could not be captured as part of the initial pivotal studies. I think you would have to look at the regulatory strategy for each program to determine the reason. I am not aware of any change in Guidance or Regulation that would move sponsors toward this change in the landscape for these trials.

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    Glen Park
    Jersey City NJ
    United States
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  • 3.  RE: Blinded Extension Studies

    Posted 04-Sep-2018 10:54
    ​Agree with Glen. For us, our extensions are generally with the IMP only.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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