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PharmD as Principal Investigator: Interventional new drug study

  • 1.  PharmD as Principal Investigator: Interventional new drug study

    Posted 28-Jan-2020 12:42
    Does anyone have experience with using a PharmD as Principal Investigator for an interventional new drug study, (they want to list the MDs who will be seeing, enrolling, prescribing the drug and treating the patients as sub-investigators)?
    Please advise, thank you.

    ------------------------------
    Terry Schuenemeyer RAC
    Director Regulatory & Clinical Affairs
    Alvin TX
    United States
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  • 2.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 08:22
    FDA, at least, is on record as stating that a principal investigator can be a PharmD, PhD, NP, etc., as long as they have appropriate experience and training and there is an MD as a subinvestigator responsible for medical care.

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


  • 3.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 09:05
    Thank you Glen for your response - it was very helpful!
    Terry

    --
    Terry Schuenemeyer, RN, MS, RAC, CCRA
    237 McLemore Drive
    Alvin TX 77511

    phone: 832-221-2774



    Original Message


  • 4.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 08:30
    I have seen PhDs, DVMs, PAs, NPs...a PharmD is as good as any of those.  I agree that an MD should have some involvement - seems fine to have them as Sub Investigators.

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    Beth Weinberg
    Regulatory Affairs Lead
    Carmel IN
    United States
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    Original Message


  • 5.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 08:35
    Edited by Julie Omohundro 29-Jan-2020 08:37
    Yes.  Sometimes an MD is really not the best background for a particular study, although I will echo the need to have one involved.

    Will this information be included in the IND application?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 6.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 08:59
    There is no requirement that the PI will be an MD.

    From the FDA Q&A around the 1572:

    4. Must the investigator be a physician?

    The regulations do not require that the investigator be a physician. Sponsors are required to select only investigators qualified by training and experience as appropriate experts to investigate the drug (21 CFR 312.53(a)). In the event the clinical investigator is a non-physician, a qualified physician (or dentist, when appropriate) should be listed as a subinvestigator for the trial and should be responsible for all trial-related medical (or dental) decisions. (ICH E6 section 4.3.1; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf)


    In practice, when appropriate to have a PI that is not MD, there should be a plan on whom will responsible for participants care in case of need and who will be responsible to make clinical assessment.

    In other words, it is bad practice to have a set of rotating MD that do those tasks - there should be one responsible MD that would be in charge on the clinical activities and that should be clearly described. Most IRBs would like to understand that as well, so it is not a bad idea to include that description in the protocol.

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    Shy Shorer MD, MBA, EJD
    Director, Office of Sponsor and Regulatory Oversight
    Center for Cancer Research
    National Cancer Institute
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    Original Message


  • 7.  RE: PharmD as Principal Investigator: Interventional new drug study

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jan-2020 09:19
    This message was posted by a user wishing to remain anonymous

    Good Morning,

    Having worked at a number of academic medical centers that conduct IND trials, I have seen this questioned or not allowed at the institutional level on a study by study basis, because of an IRB/ethics review concern, or because of specific institutional policy that places limits on what credentials are needed to be the clinical / principal investigator or the IND holder.  As mentioned above, the FDA does not impose this restriction for either Clinical Investigator or IND holder,. Having individuals with the experience to provide adequate medical expertise listed as sub-investigators on the 1572 / in the protocol is important, as is ensuring appropriate documentation over the life of the study of the responsibilities delegated by the clinical investigator and those subinvestigators' expertise to carry out those delegated responsibilities.
    Original Message


  • 8.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 10:00
    According to FDA regulations, this is perfectly fine.  the PI does not need to be a MD.  AS you describe, the MD who enrolls subjects and provides medical care can be a SubI.  It is important in this scenario that the MD(s) sign off on all medical decisions, etc.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Huntington Beach CA
    United States
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    Original Message


  • 9.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 30-Jan-2020 09:33
    I'll just add another voice to the chorus about the need for a credentialed PI. As noted the FDA only requires training and experience for a PI. Several years ago we conducted studies on HIV diagnostics with a nurse practitioner having considerable experience as the PI at a particular site. She was quite knowledgeable and this was acceptable to the FDA.

    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


  • 10.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 13:24
    Edited by Julie Omohundro 29-Jan-2020 14:10
    I will add that I wouldn't assume you can plug a PharmD, DVM, PA, or whomever in as the PI of any study that you please.  I would want to have a good rationale as to why their background makes them appropriate as the PI for the particular study.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 11.  RE: PharmD as Principal Investigator: Interventional new drug study

    Posted 29-Jan-2020 14:08
    Absolutely agree.  There is always the requirement that the PI be, "qualified by education, training and experience' to serve as PI.  This applies no matter what degree they have.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Huntington Beach CA
    United States
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    Original Message


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