Regulatory Open Forum

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  • 1.  Switching From IND Exempt to IND Required

    Posted 16 days ago

    Hello All,

    I work for a large academic center and we have just started enrolling for an IND exempt investigator initiated trial of a drug that is currently marked in the US. We are considering changing our primary outcome based on new data from a different trial of the same drug. The goal of shifting our primary outcome is to use this trial as basis for a new indication of the drug. My question is, is it even possible to switch from IND exempt to IND required once a trial has started enrolling? Has anyone done this before? Thanks for your help!



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    Julie Porter
    The Johns Hopkins University
    Renton WA
    United States
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  • 2.  RE: Switching From IND Exempt to IND Required

    Posted 15 days ago

    This is a really interesting situation. First off, I would certainly get input directly from the FDA review division and get their input.

    My thought is that you would likely need to end this first study and propose a new study which would be conducted under an IND. You mention your changing the primary endpoint, but it also sounds like you're likely  changing the purpose/objective of the study as well. I imagine the IRB would view this study differently as well. Also, if you want to use the study to support a labeling change (it being an adequate and well controlled study), you'll very likely want input on the study design from the review division, so it would make sense to just develop a new protocol rather than try and amend the existing study.



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    Michael Matthews RAC
    Director of Regulatory Affairs
    Frederick MD
    United States
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  • 3.  RE: Switching From IND Exempt to IND Required

    Posted 15 days ago

    I also work for a larger academic center.  We have done this recently with a drug through CDER.  It was initially granted IND exempt but we changed the dose to an unapproved dose (also resulted in change in delivery method) and went back to the FDA and requested them to re-review to see if we needed to now hold an IND.  We did make it clear that the study had already been started and they were okay with us switching to an IND mid-study.  Happy for you to message me separately to discuss further.



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    Lauren Wallace RAC
    Director of Clinical Research Regulatory Affairs
    Virginia Commonwealth University
    Richmond VA
    United States
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  • 4.  RE: Switching From IND Exempt to IND Required

    Posted 15 days ago

    Julie,

    I think a different question you need to address is whether you/JHU can change the drug's label. Does Johns Hopkins own the drug? Are you working with the company that owns the drug and they will use the results of the study to change their label (and if so, why aren't they holding the IND)?  If "no" is the answer to both of these questions, then you don't have standing to change the label with a new indication.



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    David Jensen PhD, RAC
    Senior Regulatory Affairs Scientist
    Durham NC
    United States
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  • 5.  RE: Switching From IND Exempt to IND Required

    Posted 15 days ago

    I think technically there is not a process issue with closing a non-commercial IND and opening a commercial IND and filing the ongoing trial to the new IND. I have started clinical trials outside the US and then opened an IND with the ongoing trial, so it is possible. The issue could be, as Michael mentions, how the conduct of the trial is impacted by changing the primary endpoint: the review division may not view the protocol the same if there is now an intent to use it for a marketing application. Discussion of the intent and process for the changes you are proposing would make a great set of questions for a preIND meeting.



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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