The Daily

Quality Fraud by Omission


More Than Half of Failed Clinical Trials Unpublished


Less than half of failed clinical trials are published in peer review journals, according to a new study. Practically, this may be due to the fact that there are no sponsors or financial stakeholders willing to contribute to a public relations push when their new ‘wonder drug’ fails. If the result is an unequivocal failure (and cannot be spun), it would make sense that tents are simply folded and the army moves on to another battlefield.

“The pivotal trial results were published in peer-reviewed journals for 138 of the 344 (40%) failed agents. Of 74 trials for agents that failed for commercial reasons, only 6 (8.1%) were published. Roughly half of investigational drugs entering late-stage clinical development fail during or after pivotal clinical trials, primarily because of concerns about safety, efficacy, or both. Results for the majority of studies of investigational drugs that fail are not published in peer-reviewed journals.” JAMA Internal Medicine October 2016

But are the negative results any less important to physicians and consumers than positive ones? What about the patients who have been started on ‘trial’ medicine? There can be as much learned about a ‘trial’ failure as a success that results in an IPO or a mass media blitz. How do consumers and patients learn when there aren’t any results published?

A failed trial of a new anticoagulant, for instance, may be helpful – even essential – for those prescribed another anticoagulant for label or even off label use. There is no way for patients or their doctors to consider new negative information if it is not published. Peer review publications set the standards for medical practice. If peer review literature only included information from positive clinical trials, doctors and consumers would never know when to stop dispensing and taking pills. Sins of omission can create quality fraud as surely as direct misrepresentations of a drug treatment’s benefit.

Educate yourself about your medical condition and your family’s conditions. This may research and investigation, along with a long discussion with your physician about treatments that may or may not work best for you. And if you or your family suffer serious injury due to negligence, show as much care in choosing your lawyer.