Delays in filing findings on new treatments mean patients aren't informed, researcher says
WebMD News from HealthDay
By Dennis Thompson
WEDNESDAY, March 11, 2015 (HealthDay News) -- 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.
source : Most Clinical Trial Results Not Reported on Time to Government