A new research found that many entities performing clinical trials fail to disclose the results of their findings in a national register within a year of their termination. Surprisingly, the federally-funded trials have the lowest transparency rate, while pharmas performed much better than expected.
The new study shows that only 10 percent of the clinical trials conducted in the U.S. have their report results made public on ClinicalTrials.gov in due time. Dr. Monique Anderson, lead-author of the study and cardiology expert at the Duke University’s School of Medicine, said that her team was surprised to learn that the final reporting of the clinical trials was not “timely,” while hardly anybody was doing it.
Patients are deprived of crucial information
Researcher explained that failing to report the results of a clinical trial deprive patients of valuable information, which can be critical if these patients have a life-threatening condition. For instance, many patients want to learn whether the miracle drug tested had positive and long-term effects, but no such data is available for them.
“My savvy cardiology patients want to know about the results of clinical trials, and how these results will affect them. If we’re making a promise to make those results available, we should uphold that promise,”
Dr. Anderson stated.
ClinicalTrials.gov was established by the Congress in 2000 as a publicly-available report on the clinical trials’ status. In 2007, lawmakers required from the sponsors of such trials to report basic results on the site so all U.S. citizens could make an idea of how successful those trials were.
Researchers said that they needed to find evidence o back previous concerns that the industry may selectively disclose the results of their trials, while medical journals may report only the positive results that benefit the industry.
Between 2007 and 2012, both the industry and the government failed to properly report the results in many of their trials. Out of 13,000 clinical trials, only 13 percent were reported on time, i.e. within the one-year window required by the law. Nearly 85 percent of these trials investigated the efficacy of new drugs, while two-thirds were funded by the private sector, scientists found.
The new study was published March 12 in the New England Journal of Medicine.
Pharmas scored better
Ironically, pharma groups had a better score at reporting the findings of their research departments than government-sponsored institutions and agencies. Industry-funded trials had a reporting rate of 17 percent in the first year, while this rate rose to 41.5 percent within five years of the trials’ completion.
On the other hand, clinical trials sponsored by the National Institutes of Health (NIH) had only an 8 percent reporting rate for their clinical trials within the first year, while trials funded by other government agencies scored even lower on the transparency scale with a mere 6 percent.
After five years since their completion, NIH-sponsored clinical trials had 39 percent reporting rate, while other federally-funded trials had only 28 percent. Dr. Anderson commented on the situation and said that she was “really shocked with the finding that NIH-sponsored research had such a low transparency rate.
Researchers overwhelmed by the ‘administrative burden’
Kathy Hudson, spokesperson for the NIH, said that the poor reporting rates revealed by the new study were “simply unacceptable.” Ms. Hudson also disclosed that the institute recently proposed a policy that would force all NIH grantees to transmit their clinical trials’ final results or else they would lose their funding.
Laurin Mancour from the Association of Clinical Research Professionals described the results as “disappointing”, but explained why researchers fail to comply with the one-year deadline. According to Ms. Mancour, after the completion of a clinical trial, the governmental resources get allocated to other projects, so researchers have to get along without the funding when trying to report in due time. Also, researchers fail to cope with this additional “administrative burden” mainly because it is not within their domain of expertise, Ms. Mancour added.
However, ClinicalTrials.gov does allow an exception from the within-one-year reporting requirement for researchers that want to put on sale a new drug or device but their Food and Drug Administration approval is pending.
Taking into account that exemption, the study-authors found that the industry complies with the legal reporting requirements for their trial by about 80 percent. Several other delays were also due to legally acceptable reasons.
Dr. Anderson said that pharmas were “legally doing their job.”
However, after researchers took into account the exemption, only 45 percent to 50 percent of the NIH-sponsored trials were legally reported.
But the research team is pleased with the results because they are reassured that those unfair practices reportedly carried out by the industry seem unfounded. Those practices were the first reason ClinicalTrials.gov emerged, researchers explained.
Jeff Francer, a big pharma trade group’s representative, recently reported that the biotech companies planned to further improve their publicly reporting scores for their clinical trials.
Mr. Francer also said his trade group was encouraged by the NEJM paper’s findings that the industry seem to report clinical trial results on a regular basis and display “strong reporting rates” compared to federally funded research groups.
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