It’s now been five years since a group of medical-journal editors led by the Journal of the American Medical Association called for researchers to register their patient trials in advance so they could not hide unwanted outcomes.
A study to be published on Wednesday, however, suggests that the effort may not be working as planned.
The study, led by Sylvain Mathieu, an assistant professor of rheumatology at Bichat-Claude Bernard, a teaching hospital in Paris, reviewed 323 human medical trials in cardiology, rheumatology, and gastroenterology that were published last year in 10 general medical journals and the 20 specialty medical journals in those fields with the “highest impact factors"—that is, the most influential journals as measured by citations from other researchers.
The review found that only 45 percent of the published trials were “adequately registered,” meaning they were registered before the end of the trial with the expected primary outcome “clearly specified,” the authors said. Registration was altogether lacking for 27 percent of the published trials, and the trials were registered after publication in 14 percent of the cases.
The editor in chief of the Journal of the American Medical Association, Catherine D. DeAngelis, said she was satisfied that the policy adopted in 2004 was making a positive difference.
At least 300 journals are adherents of the policy, Dr. DeAngelis said. And of the 20 top-ranked journals, only about four publish the results of clinical trials, and at least three of those four have adopted the policy, she said.
Before 2004, “it would have been pretty close to zero” journals requiring researchers to register their patient trials in advance, Dr. DeAngelis said. “I am very happy” to see the progress in five years, she said.
The journal, known as JAMA, pushed for the registry system in 2004 after finding growing evidence that pharmaceutical companies and their researchers were hiding unfavorable results of clinical trials. One case involved Paxil, an antidepressant made by GlaxoSmithKline, which admitted that test results suggested a possible increase in suicidal tendencies in children. That admission helped settle a lawsuit against the company filed by New York’s attorney general.
Even among the 45 percent of trials that were adequately registered last year, 31 percent of their published reports showed “some evidence of selective outcome reporting,” Dr. Mathieu and colleagues wrote in a report on the study, which appears in Wednesday’s issue of JAMA.
A spokeswoman for JAMA, Jann Ingmire, said her publication had abided by the rules established in September 2004, when JAMA and the editors of 12 other journals committed themselves to publish only the results of trials that were registered in advance and called on their colleagues at other publications to do the same.
A co-author of the study, Philippe Ravaud, a professor of epidemiology at Bichat-Claude Bernard, affirmed that the problems primarily involved the specialized journals. “The general journals performed perfectly,” Dr. Ravaud said.