Most Clinical Trial Results Not Reported on Time to Government

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Researchers are not promptly reporting the results of clinical trials to a government website specifically created to make the findings of these studies known, new research shows.

Only about one out of 10 clinical trials met federal requirements to report their results on ClinicalTrials.gov within one year of the study’s completion, researchers found.

“We were really surprised to find that reporting certainly isn’t timely, and hardly anybody is doing it,” said study author Dr. Monique Anderson, a cardiologist at Duke University School of Medicine, in Durham, N.C.

These delays can rob patients of valuable information needed to treat serious and potentially life-threatening ailments, Anderson said.

“My savvy cardiology patients want to know about the results of clinical trials, and how these results will affect them,” she said. “If we’re making a promise to make those results available, we should uphold that promise.”

In 2000, Congress authorized the creation of ClinicalTrials.gov to publicly report information about clinical trials, the authors said in background information. Seven years later, a new law expanded the website’s mandate, requiring sponsors of most trials to report basic summary results so Americans could have access to the data.

“There’s been a lot of prior concern that industry often withheld evidence that came to light later about their medical products, and that medical journals were selectively reporting the positive results from trials,” Anderson said.

However, transparency has generally been poor among more than 13,000 clinical trials completed within the first five years after Congress expanded reporting requirements for ClinicalTrials.gov, Anderson and her colleagues said.

An average of slightly over 13 percent of researchers running eligible trials reported their findings within the required one-year window, according to the study published in the March 12 issue of the New England Journal of Medicine.

Private industry actually performed better than academic or publicly funded researchers in posting results, the study authors reported.

Among the studies in the analysis, nearly 85 percent were designed to investigate a new treatment, and two-thirds of the trials were funded by private industry.

The one-year reporting rate for industry-sponsored trials was 17 percent, the findings showed. Within five years, results had been posted for 41.5 percent of industry-funded trials.

By comparison, the one-year reporting rate was about 8 percent for clinical trials funded by the U.S. National Institutes of Health (NIH), and just under 6 percent for trials funded by academic institutions or other government agencies.

At five years, almost 39 percent of NIH-funded trials and close to 28 percent of academic/non-NIH-funded trials had reported results.

“I was really shocked with the fact that NIH-funded research was doing so poorly in terms of transparency,” Anderson said.

Kathy Hudson is deputy director of science, outreach and policy for the NIH. She said: “The poor results reporting of NIH-funded clinical trials to ClinicalTrials.gov described in the new study are simply unacceptable. They confirm the need for NIH’s newly proposed policy that requires all NIH grantees to submit clinical trial results information or risk losing their funding.”

The reporting requirements for ClinicalTrials.gov do allow researchers to delay submitting their data if they want to market a new drug or device and are awaiting approval from the U.S. Food and Drug Administration, Anderson added.

Taking that into account, the researchers found that about 80 percent of industry-funded trials either met the reporting requirements or had a legally acceptable reason for delay.

“We found that industry is really legally doing their job,” Anderson said.

But NIH-funded and academic trials continued to lag, even with this caveat. Only half of the NIH-funded trials and 45 percent of academic trials either met requirements or had a legally acceptable reason for delay, the researchers found.

The private pharmaceutical industry’s relative success at meeting these requirements is encouraging, given that concerns over their practices were what prompted the founding of ClinicalTrials.gov, Anderson said.

Biopharmaceutical companies recently adopted a set of principles that will further improve public reporting from clinical trials, said Jeff Francer, vice president and senior counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA).

“While we are still reviewing the NEJM article, PhRMA is encouraged by findings that industry sponsors of clinical trials appear to be reporting trial results regularly and have strong reporting rates when compared to researchers funded by the government or academia,” Francer said.

Laurin Mancour, a trustee with the Association of Clinical Research Professionals, said the study’s results are “disappointing” and illustrate the severe administrative burden that many researchers face in meeting the reporting requirements.

After a clinical trial has closed, “your resources have been allocated elsewhere, to other projects,” Mancour said. Researchers have to meet the one-year deadline without the help they had on hand during the clinical trial, she explained.

“Part of the challenge is how much do we need to disclose to the public, and at what point does this become such an administrative burden that we don’t do it very well,” Mancour said.

Study author Anderson said the new rules the NIH has proposed would further increase transparency by requiring all NIH-funded clinical trials to meet the one-year deadline, even those of drugs submitted to the FDA for approval.

Those who fail to submit data within the one-year reporting period could face penalties as high as $10,000 a day and the loss of NIH funding, she said.

“I don’t think institutions want to deal with $10,000 fines,” Anderson said. “I think we will see an increase in transparency, especially if true enforcement of the law occurs.”

More information

Read the proposed new rules for ClinicalTrials.gov at the U.S. National Institutes of Health.

Source: HealthDay

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