Regulatory Open Forum

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  • 1.  Scientific and educational activities

    Posted 05-Mar-2012 20:51
    Hello all，

    Our company is going to conduct clinical trials of modernized Traditional Chinese Medicine in the U.S.
    Since it is our first time doing such trial in the US, we propose to create several videos, including introduction of our company and our product, guidelines of the test method, in order to let investigators and subjects know better of the trial.
    What are restrictions of the contents of the video?
    What are restrictions of presenting the video?
    What practical methods could help us be educational and non-promotional?

    Thanks very much for any responding!

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    Yu Hong
    Malden MA
    United States
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  • 2.  RE:Scientific and educational activities

    Posted 06-Mar-2012 11:19
    You must be very careful, particularly with a video.  A simple video introducing your company is ok, but you cannot have any more than a general discussion of the types of products you plan to offer in the future (e.g., "will be designed to treat/diagnose...") if they are not cleared/approved in the US.  There should be no discussion of specific application, safety, or effectiveness. 

    An introduction to the company (depending on actual content) is ok for a general distribution.  However, any video or other materials regarding potential clinical trials or methods can only be directed as recruitment for potential investigators, and limited to controlled forums appropriate for such recruitment (e.g., one-on-one presentations to physicians; certain meetings or conferences where potential investigators are the primary participants).  Again, this should avoid specific discussion of safety and effectiveness other than stating what is being investigated.  You should not be presenting to potential subjects, except the mandatory postings of current clinical trials (once started) as required.  Subject enrollment is the responsibility of the investigators.

    Good luck with your investigations!  Perhaps it would be worthwhile in the beginning to work with a consultant who has experience with clinical trials and investigator recruitment. 

    Peter

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    Peter Takes PhD, RAC, FRAPS
    Senior Director, Clinical & Healthcare Compliance & Clinical Compliance Officer
    Stereotaxis Inc
    St Louis MO
    United States
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