Regulatory Open Forum

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  • 1.  Investigator Initiated Trials

    This message was posted by a user wishing to remain anonymous
    Posted 27-Apr-2018 08:59
    This message was posted by a user wishing to remain anonymous


    Can you use data from Investigator Sponsored Trials and submit it to the FDA? For e.g. create a clinical study report (if you have access and agreement to use the investigator's data)?
    What are some of the challenges you may expect or the limitations of such an approach?


  • 2.  RE: Investigator Initiated Trials

    Posted 27-Apr-2018 09:55
    ​Submit to the FDA to seek approval? If so, was there any previous discussions with the FDA regarding the requirements for filing and approval of your proposed target indication? Lot of factors go into this decision. Was this an already marketed entity and going for an additional indication, or new entity/new indication, unmet medical need/Orphan indication, etc etc........Depending on all these factors, one can create en effective regulatory strategy to start discussion with the FDA (i.e. with an appropriate review division) to seek approval.
    Hope this helps


  • 3.  RE: Investigator Initiated Trials

    Posted 03-May-2018 10:10
    ​The short answer is yes, you may use data derived from an Investigator trials assumingly when you have provided the investigational drug to the investigator for evaluation.  The primary challenge would be whether the study was conducted in accord with GCP standards and FDA regulations and whether you have assurances that the data meets standards for ALCOA (attributable, legible, contemporaneous, original and accurate).

    Michael Trapani
    Senior Consultant
    Monroe Township NJ
    United States