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  • 1.  conflict of interest - clinical trials

    This message was posted by a user wishing to remain anonymous
    Posted 09-Nov-2022 10:42
    This message was posted by a user wishing to remain anonymous

    Hi everybody, 
    I wonder if an employee at the sponsor's company can act as the principal investigator of a trial and whether it is sufficient to disclose this conflict of interest or any other precautions should be taken.
    Thanks in advance for your kind responses.

  • 2.  RE: conflict of interest - clinical trials

    Posted 10-Nov-2022 07:42
    You could start with reading 21 CFR 312:

    Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.

    That implies that conflict of interest is stated. Now the implications of THAT depends on the study design/phase/etc.

    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States

  • 3.  RE: conflict of interest - clinical trials

    Posted 10-Nov-2022 10:10
    Hi Anon.

    I would agree with Glen's point that the regulations do not explicitly preclude (and it is easy to argue that they actually include) the possibility of a company or employee both being a sponsor and an investigator.  Think about it - I would say it happens with more regularity than would be expected at first glance - with doctors who are parts of "medical boards" (I know - most of these folks are "independent contractors" but they are still receiving remuneration from the company for something other than acting as a treating physician!) who also act as PIs on that company's clinical studies.

    I also think that the implications of the question of the conflict are very dependent on what you are going to be doing, how far into the development cycle you are (is this a Phase I bioavailability study or is this a Phase III pivotal approval study) and these implications must govern what guardrails are put into place.  I think it also might be wise to consider who the employee is, what their role in the company is, and more importantly what, if any, direct impact the success or failure of the study might have on them personally (financially, promotions, etc.) because that may prove to be more or less impactful on how you manage the conflict.

    Ultimately, it needs to be "good science" that paves the way forward.  So, you can have a conflict (as Glen noted the regulations actually appear to already expect that to happen at least sometimes) and that conflict needs to be mitigated to the greatest extent possible in order to ensure good science remains at the core of what we do.  That mitigation can take a multitude of forms depending on what the conflict review uncovers including things like "Great Wall" management (investigator cannot be involved in any part of the management of trial work except for following their own patients) to something seemingly simple like ensuring that the individual has no access to the blinding information or the production information for the clinical supplies or anything in between.

    Only you and your company can determine what are reasonable and necessary safeguards for your trial (along with advice potentially from your IRB/Ethics committee and even the regulator in some instances) because only you and the company know what the stakes are for the results of the trial.  Wish I could be of more help on this but really it goes back to the old adage from Regulatory Professionals for decades - the answer ultimately becomes "it depends"...

    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States