Regulatory Open Forum

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  • 1.  Clinical Trial Recruitment

    This message was posted by a user wishing to remain anonymous
    Posted 04-Feb-2020 16:59
    This message was posted by a user wishing to remain anonymous

    Not really a regulatory topic,  but thought I would give my inquiry a shot here:
    Does anyone have experience with using a clinical trial recruitment service? I am interested in rough estimate on lead time from contact to contract to on-boarding and outputs of recruitment analysis. Also looking for general opinion on whether a service is warranted for a small RCT ( < 5 institutions participating) of a NSR therapeutic medical device. Any other insight would be tremendously helpful. 

    Thank you!


  • 2.  RE: Clinical Trial Recruitment

    Posted 05-Feb-2020 10:34
    I have experience with clinical trial recruitment services - most recently with a company that uses social media. They seem to be most useful for studies where the investigator needs to recruit outside their practice or available patient databases and can provide pre-screening services with referral if they pass the general screening (i.e., age, gender, diagnosis and other inclusions and exclusions that do not require physician examination/testing). Contracting seems to be fairly quick, and would be particularly for a NSR device not requiring IRB approval. It is always a challenge to determine whether they are cost-effective and the most important metric is the percentage of screen failures that get referred by the service. I think the size of the trial and number of centers is less important than whether the investigators need assistance in identifying patients outside their practice/database.

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