Even though various federal laws were designed to promote clinical trials for testing products in children, a notable number of research is either not published or not completed, according to a new study. And the study authors say this is a problem because unpublished results violate ethical imperatives and cause medical literature to be incomplete.
Specifically, the researchers found that 19 percent of 559 randomized clinical trials, or 104 studies, were discontinued. Of the 455 completed trials, 30 percent, or 136 studies, were not published, according to the study, which was published Thursday in Pediatrics. More than 69,000 children participated in those studies, by the way.
Moreover, the clinical trials that were funded by industry were more than twice as likely to remain unpublished two and three years after completion. They also had a longer mean time to publication compared with trials that were sponsored by academia — 33 months versus 24 months. Drug makers were responsible for two-thirds of all trials and all of the completed trials.
Overall, the clinical trials that were sponsored by industry were more likely to be completed than those sponsored by academia, although completed trials sponsored by industry were less likely to be published than trials sponsored by academia.
The findings come amid ongoing tumult over the disclosure of clinical trial data.
Over the past decade, the pharmaceutical industry has come under fire following scandals in which side effects were not fully disclosed. Drug makers argue that disclosing certain data may compromise trade secrets or patient privacy. Consumer groups counter that such information is kept out of reach at the expense of patients. And researchers say results cannot be duplicated without access to data. Even some investors have pushed for greater disclosure.
Since then, various efforts have begun to peel back the data curtain, such as an initiative led by GlaxoSmithKline that has been joined by other companies. But there is still debate, which can be seen this week in The New England Journal of Medicine, where some researchers expressed fears that providing too much disclosure can lead to inaccurate or misleading analyses.
And so, the authors of the Pediatrics study say the potential for harm is too great not to push for publication.
“There has been a lot less evidence available for treating children with certain products than compared with information concerning adults. And this is because, historically, there was a lot less research conducted in children,” said Dr. Florence Bourgeois, an assistant professor of pediatrics at Harvard Medical School and Boston Children’s Hospital.
“There were many more barriers to conducting studies — some were ethical or financial. But as a result, as much as 80 percent of medications given children were off label,” Bourgeois said. “So now we have legislation that encourages or, in some cases, requires studies. But do we have more of that evidence reaching clinicians at the point of care? Our findings indicate that not enough is being made available.”
The legislation she mentioned is the Best Pharmaceuticals for Children Act, which provides an incentive for drug companies to conduct FDA-requested pediatric studies by granting an additional six months of marketing exclusivity, and the Pediatric Research Equity Act, which requires drug companies to study their products in children under certain circumstances.
Bourgeois added that while most patients do not benefit directly from the research, there is a social contract that any benefits from the scientific information that is gathered should be available. And she pointed to the Declaration of Helsinki, which states that investigators are responsible for the public dissemination of trial results involving human participants, regardless of the findings.
So what to do?
The study authors pointed to RIAT, or Restoring Invisible and Abandoned Trials, which “invites researchers with unpublished trials to signal their intent to publish the trial within a year or else provide public access to their trial results and offer the opportunity to independent investigators” to review and duplicate the work.
The authors also noted that since the FDA Amendments Act of 2007 requires results to be reported but not specifically publication, trials can be reported on ClinicalTrials.gov.
RIAT, trying to remember what that stands for tomorrow would be a good test for early dementia. Having run a pediatric exclusivity program for an older approved product I can say with a degree of certainty that publication is NOT a major goal. You get only six months of exclusivity; it generally takes longer than that to get a paper published. Our goal was effecting a pediatric label expansion, which was achieved, the new labeling to be in existence long after the exclusivity had expired. Plus, we didn’t want to spend money on reprints to send to all our friends and relatives who wouldn’t read or understand the papers.
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