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July 7, 2005 

Clinical Trials Registration: Overdue yet Elusive

Perhaps half of the 60,000 clinical trials ongoing in the United States will never be published in a scientific journal, according to Kay Dickersin, PhD, the new director-designate of the Department of Epidemiology’s Center for Clinical Trials. Patients as well as the scientific community are harmed when deprived of all these findings.

Kay Dickersin, PhD

Kay Dickersin, PhD

At the Bloomberg School on July 1, Dickersin reported her investigations about exactly what becomes of research results in the United States. When she asked a group of investigators why they didn’t publish some of their findings, 22 percent said they had never finished the work; 11 percent said publicity had not been their aim; and a full 30 percent said the results were “uninteresting” (meaning, in most cases, “negative”).

“In any case,” said Dickersin, “[not publishing our results] is not really what we scientists are about.” She went on to quote Einstein: “The right to search for truth implies also a duty; one must not conceal any part of what one has recognized to be true.”

Why did Einstein use the word duty? Dickersin, currently professor of Medicine and director of the Center for Clinical Trials and Evidence-based Health Care at Brown University, listed several well-known cases where inaccessible information from unpublished studies could have reduced patient risk—or even saved lives. 

Said Dickersin, “Failure to publish has definitely had harmful effects for patients.”

But how is science hurt when results are buried? She ticked off a number of downsides: expensive duplication of effort; lost opportunities for collaboration; underreporting of negative results—even ethical problems, since “we are breaking a covenant with the participants in clinical trials” when we assure them they will be contributing to new knowledge but then fail to publish results.

What can scientists do? First, said Dickersin, the scientific community must create a standardized, all-inclusive, unified registry of every clinical trial initiated, wherein all results must be entered. She added that many partial registries of clinical trials currently are up and running but that none is comprehensive and they contain few industry trials.

“It seems like a no-brainer to do trials registry,” said Dickersin, “but we’ve spent the last 20 years talking about it. Who’s going to take charge?” she asked. Some people are concerned that the local institutional review boards (IRBs) are too busy already, but scientists worldwide feel this may be the best approach.

Help with a genuinely global registry, however, finally seems at hand: The World Health Organization has pledged to take on the responsibility of this mammoth recordkeeping task. Add to this good news the media outcry last summer about antidepressants being linked to teen suicidal behavior, and people are starting to ask why such important results don’t surface.

Already, the members of the International Committee of Medical Journal Editors have declared they will no longer accept articles unless the studies are registered—and they are giving researchers until September 2005 to get all their past studies registered as well. Moreover, Congress is considering a bill (the Fair Access to Clinical Trials (FACT) Act, S. 470) that will amend the Public Health Service Act to expand the clinical trials drug data bank and would require the National Institutes of Health to refuse further funding if information is not submitted to ClinicalTrials.gov, the U.S. registry of drug and device trials.

Dickersin urged researchers to get involved, talk to their colleagues, write editorials and even, for instance, find out whether all trials at the Bloomberg School are registered. She asks all interested scientists to call their federal representatives in Congress about the new FACT Act. “One person can change a representative’s mind,” she said. “They’re grateful for your opinion and guidance.” —Rod Graham