In early October 2016, JAMA Internal Medicine published a paper indicating that less than half of failed Phase III clinical trials are subsequently published in peer-reviewed journals. The authors warned that the widespread failure to publish such failed trials hinders medical progress, wastes resources, and places patients in harm’s way.

The paper examined the development process of 640 drugs, of which 344 failed during Phase III. Its authors found:

“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.”


In contrast, successful trials’ publication rates are around twice as high. The authors note that typically, around 80% of successful Phase IIb-III clinical trials are published in the academic literature. (They cite three previous studies finding publication rates of 76%, 78%, and 86%, respectively.)

The authors concluded:

“[N]egative results can inform clinical practice [and] may yield new insights into the safety and pharmacology of other agents. Without knowledge of safety and efficacy issues found later in the development process, researchers may continue to bring forward investigational agents to clinical trials that are unlikely to show benefit. As a result, future research subjects might be more likely to be exposed to harms from toxic or futile treatments … Given the increasing cost of clinical trials, lack of information sharing wastes resources and diverts attention from more productive areas of research.”