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  • 1.  Expanded Access - Post Trial

    This message was posted by a user wishing to remain anonymous
    Posted 07-Sep-2021 15:14
    This message was posted by a user wishing to remain anonymous

    Hello, this question is in regard to Expanded Access (EA) post a clinical trial. Specifically the period from stopping drug on the trial to last visit (follow up). May a subject start on the EA during this period? Any issues anyone know of? Thanks


  • 2.  RE: Expanded Access - Post Trial

    Posted 08-Sep-2021 14:29
    I have been involved in providing EA for patients after a clinical trial has ended when the condition was responding to the treatment and continued treatment was needed. Of course, it might be preferable in some cases to offer a long-term treatment protocol for collecting additional safety information. In the scenario you describe with a gap between stopping drug and the final follow up visit, it might depend on why there was that gap. If the gap was needed to collect important study endpoints, the benefit risk assessment would need to be made for the patient versus the integrity of the study.

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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


  • 3.  RE: Expanded Access - Post Trial

    Posted 09-Sep-2021 09:29
    Hello.

    If you are referring to an EA treatment IND/protocol, depending on both EA and clinical trial protocols, the subject may be able to enroll and continue to receive the same (I am assuming) product.  If you are referring to an single patient EA or intermediate-population EA, one of the eligibility criteria for these routes is to confirm the patient cannot participate in existing clinical trials.  If the status of the patient is considered still active in the trial, you may need to submit justifications.

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    Ji-Eun Kim RAC, RPH, PhD
    Director, Regulatory Affairs
    Scarsdale NY
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    Original Message


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