Early Release of Clinical Research Results May Prove Harmful

A study suggests that when medical trial results are released prior to journal publication, doctors may use the data to make changes in their practice--changes that may be harmful to some patients and may not agree with the detailed results later published in a peer-reviewed journal. The study was conducted by researchers at the U.S. Agency for Healthcare Research and Quality (AHRQ), Yale University (New Haven, CT, USA), and Johns Hopkins University (Baltimore, MD, USA). The research was reported in the December 13 issue of The Journal of the American Medical Association (JAMA). Scientists and journal editors have long debated whether it is in the public's best interest to release the results of clinical trials prior to publication.

In the study, the researchers tracked the use of carotid endarterectomy (CEA) in two clinical trials. Both trials had been halted early, as potentially life-saving benefits of CEA were shown, and clinical alerts disseminated this information to doctors prior to journal publication. The alerts explained the findings of the study, but cautioned doctors that the trial included only patients under 80 and that the trials were conducted at medical centers with documented expertise in CEA.

After the alerts were released, there was a substantial increase in CEA use, about 18% over the six-month period following the first alert but then diminishing to only 0.5% after the findings were published. Following release in 1994 of the clinical alert on the second trial, the rate of use increased 42% over the next seven months. After the findings were published in 1995, however, the rate of use decreased 0.3%.

The study also found that the use of CEA after each alert was greater among patients over 80, despite the fact that such patients would not have been eligible for the trials. In contrast, following publication of the trial findings, there was a greater decrease among those 80 and older. Despite the warnings in the alerts, the researchers also found that many patients were referred to hospitals with less experience in the use of CEA than those in the trials.

"Future research could focus on how clinical alerts--the means used for alerting clinicians early to trial findings--might be structured to preserve their advantage while avoiding any potential downside,” said AHRQ researcher, Claudia Steiner, M.D., a coauthor of the study.