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Up to 16% of Clinical Trials May Fall Outside of Federal Safety Regulations

March 5, 2014 | A research letter published today found that 5% to 16% of clinical trials do not fall under federal regulations that oversee "human subjects protections". It doesn't mean that the trials have no patient-safety monitoring, but that they fall into the category of "gap trial", which could include trials that are not receiving federal funds or are testing a surgical procedure or behavioral therapy.


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