Tuesday, March 10, 2015
Nearly 4 in 10 clinical trials based on false information
"One of the most important responsibilities of the Food and Drug Administration (FDA) in protecting public health is to conduct regular inspections of clinical trial sites to ensure that good clinical practices are being followed. But a new study published in the peer-reviewed journal JAMA Internal Medicine has found that nearly half of all clinical trials are based on false information, and the FDA typically does nothing to address this widespread problem.
Charles Seife, M.S., from the Institute of Journalism at New York University conducted a cross-sectional analysis of publicly available documents that describe FDA inspections of clinical trial sites where significant evidence of objectionable conditions or practices was found. Narrowing down the pool to only those documents that contained enough information to fully identify the violations described, Seife came up with 57 trials for which evidence of "significant departures" was abundant.
These significant departures included underreporting of adverse events, violations of protocol, violations of recruitment guidelines and various other forms of scientific misconduct. And based on these criteria, a shocking 22 trials, or nearly 40% of those sampled, were verified to contain data that the FDA had determined to be falsified."