FDA rarely reports violations during clinical trials: Study

A new review of U.S. Food and Drug Administration (FDA)  inspection reports between 1998 and 2013 revealed that the FDA rarely reported violations of scientific conduct exposed by federal regulators during spot inspections of clinical trials.

A research team led by Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University, examined 57 clinical trials that received a notice of violation from the FDA for poor record keeping, false information, and poor patient study.

"Since the FDA's evidence of misconduct -- even of fraud -- seldom makes its way into the peer-reviewed literature, researchers and doctors are unaware that they're making life-and-death decisions based upon experiments whose reliability has been called into question," explained Seife.

"Official action indicated" (OAI) is reserved by the FDA for the most severe forms of clinical trial violation found during the regulator's site inspections: "objectionable conditions or practices" that warrant compulsory regulatory action, as opposed to "voluntary action indicated" for lesser violations.

The study found that only 4 percent of publications mentioned the violations recorded in FDA inspections mainly because the agency does not make the effort to tell journals that a clinical trial has been given an OAI during inspection nor is there a general announcement informing the public of the misconduct revealed in a certain study.

"The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA's allegations of research misconduct," concluded Seife.