Doctors rely on clinical trial data when determining whether to recommend
treatments to their patients. Unfortunately, the medical studies often
fail to provide a clear picture of the treatment’s effectiveness
and potential safety risks.
Not surprisingly, the clinical trials that result in success are the ones
that get published and are easy to locate. Meanwhile, studies that reveal
safety concerns or prove the treatments to be ineffective are often not reported.
Clinical Trials Often Unregistered and Unpublished
In the most recent study, researchers examined 113 clinical trials approved
in Finland in 2007. It found that the clinical trials were often unregistered,
unpublished, and discrepant in the reporting of primary outcomes.
Reuters reports, only 61 percent of the trials appeared in public registries within one
month of the trial start date, and just 57 percent were ultimately published.
One in five clinical trials failed to define a primary outcome, or establish
clear protocols for assessing if the tested treatment had achieved its
Among the unregistered trials, 55 percent of the results that were published
had discrepancies. They included altering a primary outcome after the
trial started or lowering the standard for determining whether the treatment
met its main objective in the experiment.
The Importance of Clinical Trial Transparency
While the study involved a small sample, its findings reflect a growing
problem. Previous research that analyzed reporting from large clinical
trials registered on ClinicalTrials.gov found that 23 percent of the clinical
trials failed to report any results.
“Doctors rely on published evidence to guide patient care decisions,
while researchers use the published literature to guide which promising
areas of inquiry to pursue,” said lead study author Dr. An-Wen Chan
of the University of Toronto.
“When research is hidden from view, then this evidence is unavailable
to guide patient care or future research,” she told Reuters.
San Diego injury lawyers, we agree that failing to report the results of pharmaceutical and medical
device research can compromise patient safety. Without transparency, it
is impossible to make an informed treatment decision.
If you or someone you love has suffered serious harm due to dangerous drug
or medical device, don’t hesitate to contact
our San Diego injury lawyers at the Law Offices of Robert Vaage for a free