Clinical Trial Data Underreported: Study

One-third of the human experiments for approved drugs failed transparency requirements.

Nov 16, 2015
Kerry Grens

PIXABAY, ADNOWAKVolunteers for clinical trials shouldn’t get their hopes up too high that data from their participation will ever get published. An analysis of clinical trials for a sampling of drugs approved by the US Food and Drug Administration (FDA), published in BMJ Open last week (November 12), found that just one-third of the clinical trials that ought to have been reported by the trial sponsors were indeed published.

“Right now, there’s a big push for evidence-based medicine. It’s impossible to have evidence-based medicine without the evidence,” Jennifer Miller, the lead author of the study, president of Bioethics International, and an ethicist at New York University’s Langone Medical Center, told The Washington Post.

Miller and her colleagues looked at clinical studies related to 12 new drugs approved by the FDA in 2012. Among the 318 trials, a median of 17 percent were subject to reporting requirements. While all of them were appropriately registered, only two-thirds complied with the law for publication. And half of the patients who volunteered for the trials never saw their results published.

Some firms performed better than others in being transparent. Johnson & Johnson, Gilead, and GlaxoSmithKline, for instance, were 100 percent compliant for the drug each company got approved. Pfizer was totally compliant for two drugs, and failed to follow the law for another. Genentech (owned by Roche) was also noncompliant for two drugs.