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  • 1.  Medical Monitor role in Clinical Trials

    Posted 26-Apr-2019 03:59
    ​​Dear all,

    I was wondering if any you could help me identify regulatory documents (FDA, EMA, PMDA, CFDA, etc.) addressing the role of a Medical Monitor in a clinical trial. This is a common, if not constant, role in pharma trials and it is (already for some years) becoming relevant in device trials.

    Is there any guidance available regarding responsibilities and interaction with other participants (and committees) in clinical trials?

    Looking forward to your message(s),

    ------------------------------
    Ernest Spitzer, MD
    Rotterdam - Netherlands
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  • 2.  RE: Medical Monitor role in Clinical Trials

    Posted 26-Apr-2019 08:52
    To my knowledge the role of Medical Monitor is not defined in US FDA or EMA regulations or mentioned in guidances. Well, except that the US procedure for FDA inspectors of clinical trials/Sponsors/CROs does mention Medical Monitor in identifying an individual responsible for conduct and safety of a clinical trial and who may be an MD. http://www.fda.gov/ora/compliance_ref/bimo/7348_810/48-810.pdf

    I am also aware from my work with NIH that most clinical research programs require assignment of a Medical Monitor. Their SOPs typically include language such as the following from the Division of Microbiology and Infectious Diseases (DMID):  The Medical Monitor (MM) will be responsible for providing safety oversight and reviewing the protocol (e.g., study halting rules) and information about the study product as it becomes available, such as the Investigational Brochure (IB), other DMID trials, and reported safety events. The DMID MM, in consultation with the protocol team and safety oversight committees, will provide safety review during the execution of the clinical trial. This oversight includes reviewing safety information and providing applicable recommendations. The DMID MM provides recommendations, as appropriate, to members of the study team, which may include, but is not limited to: DMID, the funder, manufacturer, and IND holder. This data and safety review facilitates early detection of safety signals and maximizes the chances for continued appropriateness of the research and protection of human subjects. 

    I think the term has developed within the industry consistent with the NIH view to refer to the individual responsible for a specific clinical trial or for the development of a drug overall.

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


  • 3.  RE: Medical Monitor role in Clinical Trials

    Posted 26-Apr-2019 09:24
    I concur with Glen, although I'm more inclined to think NIH took the term from industry...in this case the CRO industry, not pharma or devices.  I don't recall it being in use before the 1990s, when the CRO industry exploded. 

    Previously, pharma companies had their own clinical research departments and also a lot of "Medical Directors" who didn't direct anything, but had MDs, so they needed a good title. :)  The Medical Directors covered safety review for clinical trials, but did a lot of other stuff that required medical training and expertise as well.

    The CRO industry was largely created by pharma shedding its clinical research departments, which handled protocol development, consent templates, site selection, startup, monitoring, close-out, clinical data management.  When this department left, Medical stayed behind (as did Regulatory), but some medical expertise was still needed, so the CRO industry needed a new role, one more study-focused.

    The role as I see it is anything to do with safety or that other requires a medical judgment to be made during the course of (thus, "monitoring") the trial, and judgments for the trial, not for the patients.  Safety-related judgments for patients are in the hands of the PI who enrolled them or their personal physicians.

    But, as Glen has noted, none of this is set in stone, so different clinical research initiatives are free to structure responsibilities different ways.

    ------------------------------
    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


  • 4.  RE: Medical Monitor role in Clinical Trials

    Posted 26-Apr-2019 09:59
    ​Thank you so much Julie and Glen! Your insightful comments put things in perspective for this role. Not only from the regulatory but also the historical point of view.

    We are setting-up best practices and updating standard procedures at my institution and were hoping to identify regulatory advice. It is evident now that to some extent this is an unchartered territory.  

    I followed the link you provided, and it has been updated to: https://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133770.pdf, where indeed there is a very small reference to the medical monitor.

    All the best,

    ------------------------------
    Ernest Spitzer
    MD
    Rotterdam
    Netherlands
    ------------------------------

    Original Message


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