A new website is about to be launched in attempts to increase
transparency in clinical trials, and give consumers more information about the
effects and side effects of drugs, medical devices, and biologic products that are
continually being tested in the United States.
Since its inception in 2000, www.ClinicalTrials.gov has been a
website devoted to offering information about clinical trials. Until now, the
information it provided was limited to the dates, designs, and enrollment eligibility
requirements of various studies. This week, ClinicalTrials.gov is going to begin
including extensive data on the results of clinical trials.
The change in the website is the outcome of a rule passed
last year which requires researchers who post online information about a
clinical trial’s launch to go back within one year of the trial’s completion,
or within 30 days of FDA approval of a product, and post the results.
Previously, consumers who were interested in study results
had to seek them in specialized medical and scientific journals. Now, the
results of more than 62,000 studies will be accessible in one convenient place.
Consumer advocates are hoping this will help put an end to scenarios such as
Merck’s Vioxx scandal, in which Merck marketing executives were accused of
deliberately hiding the results of clinical trials indicating that the pain
medication Vioxx might significantly increase a patient’s risk of heart attack.
They also envision consumers having greater access, through the website, to breakthrough
drugs and treatments that might have otherwise escaped their attention.
have already suggested that ClinicalTrials.gov may not be as helpful to the
average consumer as we might hope. Whereas study results published in medical
journals are interpreted and discussed for the public by doctors, independent
researchers and other experts, results posted on the website will be published
as-is, with no professional interpretation, comments, or opinions allowed.