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Compliance In Focus
Posted by Brandy Smith on Thu, Aug 16, 2012

Dangerous Clinical Trial Loophole?

The question of the day: Should sponsors be required to publish results of clinical trials for theDangerous Loop Hole (2) public to view? A new bill proposed to the US House of Representatives would require this action. The bill titled “Trial and Experimental Studies Transparency Act of 2012” or the “TEST Act” for short, hopes to further human subject protection by ensuring disclosure of additional information surround a clinical trial.

Congressmen Edward Markey (D-Mass.) introduced the bill to close clinical trial “loopholes.” According to the press-release, “One of these loopholes results in registered trials never reporting study results, putting future human participants at risk if a different company decides to develop the same (product), but without important safety information from the previous study.”

What does this bill mean for our Industry? In short:

  • Create certainty regarding registration and reporting requirements for sponsors
  • Enhance transparency in clinical trials for doctors, patients, and general public
  • Require clinical trials to report their data regardless of FDA approval
  • Allow for increase analysis of efficacy and safety of drugs and devices
  • Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements

Take a look at the press-release and the proposed “TEST Act.” Do you think this will be more burdensome for our Industry? Or, is this a necessary step to enhance patient safety? Tell us what you think below

Photo Credit: openDemocracy

Topics: Trial and Experimental Studies Transparency Act of, Congressmen Edward Markey, Clinical Research

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