Study Says Published Papers Fail to Report Clinical Trial Violations

Feb 12, 2015

JAMA Intern Med.

A new New York University analysis found that when the FDA's finds serious problems with how medical researchers collect their data, the peer-reviewed literature often doesn't mention it.

Using documents and data from 1998 to 2013, researchers identified 57 clinical trials that received an “official action indicated” violation for reasons including inadequate or inaccurate recordkeeping, false information and poor patient safety.

And yet, among the 78 published analyses of data from those sanctioned trials, only three noted violations.

One example was found where the entire clinical trial was deemed unreliable by the FDA, and the published paper failed to make mention of this. In another example, the published paper claimed all patients reported improvement, but the FDA found that one patient had a foot amputated two weeks after treatment.

Read the JAMA Intern Med. report