Apparent Compliance

Posted by Monique Garrett on Oct 5, 2016 1:49:07 PM


Hopefully, you were able to join us for Thomas Wicks and Francine Lane’s webinar on apparent clinical trial disclosure compliance. The topic has been garnering a ton of interest. 

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Thomas and Francine have been visiting clinical trial sponsors and speaking to them about apparent compliance and all of the factors that can impact the world’s view of a sponsor’s clinical trial disclosure practices.

They have also come up with three categories for non-compliance noting that analyses of clinical trial transparency practices often report considerable non-compliance with disclosure requirements. The three types are:

  • Actual non-compliance with regulations, where the sponsors have failed to post protocols or disclose results on time
  • Apparent non-compliance with regulations, where the sponsor may have followed the letter of the law, but the publicly available data looks as if the sponsor is not compliant
  • Scope of disclosure which various groups feel is insufficient

Thomas and Francine are currently conducting complimentary analyses of sponsor disclosure data to help them better understand the nuances of these different types of compliance and what options they have to consider in order to address them.

If your organization is grappling with this topic and would like to participate in an analysis and review discussion, please contact Thomas (Thomas.Wicks@TrialScope.com) to arrange a meeting.

Webinar Recording

In the meantime, check out the recording of the webinar: Five Reasons You May Look Non-Compliant (and What You Can Do About It!)