“Fake News” on Clinicaltrials.gov? Investigations Expose Loopholes
[Posted on: Thursday, March 15, 2018] Two independent investigations by two unrelated non-profit groups show a significant number of errors on the information available on clinicaltrials.gov website regarding the status and results of the listed clinical trials. One investigation shows that about 40% of the trials that are reported to be completed and per the law should have reported their results on clinicaltrials.gov have not done so. The other investigation comparing the information on clinicaltrials.gov with its European counterpart, EU Clinical Trials Register (EUCTR), found that one in six trials incorrectly mentioned their status as “completed” or “ongoing” on the two sites. And this could be the tip of the iceberg. The rules for registering clinical trials with clinicaltrials.gov contain several loopholes that can be exploited by deceptional players. There is no independent verification of the information posted. There is no indication that FDA or NIH verifies the accuracy of information posted on clinicaltrials.gov. The information is required to be updated annually so there could be up to one year gap between the status change for a trial and it being reported on clinicaltrials.gov. Companies are expected to be truthful about the current status but there is no penalty for intentional or unintentional lethargy. The information included in the listing is frequently of limited use as one can meet the minimum reporting requirements without giving much practically useful information. Even with the laws that exist, there is no indication that NIH has ever disciplined any company so far for non-compliance. A database created by Alltrials shows that 40% of the completed trials had not posted the results more than one year after the trial completion. Although the Alltrials database itself contains several errors such as including trials that are not subject to the reporting rules and including observational trials, but it gives a general perception of non-compliance. Another survey of 10,492 trials registered on both ClinicalTrials.gov and the EUCTR showed that 16.2% reports contain discrepancy between information posted on the two trial registries. Almost 90% of these discrepancies were where a trial was marked ‘completed’ on ClinicalTrials.gov but ‘ongoing’ on EUCTR. To add to the complexity is the exploitation of clinicaltrials.gov registry to deceive patients and doctors. For a long time clinicaltrials.gov listing has been used to create a semblance of credibility for otherwise dubious clinical trials since there is practically no restrictions of what kind of trials can be listed on the website. Hence there are several clinical trials of unverified design, commercial fee-for-participation trials, and other non-credible trials listed on the site, which are used by their publishers for deceiving patients, doctors and even investors. This prompted a new disclaimer on clinicaltrials.gov warning that “listing a study does not mean it has been evaluated by the U.S. Federal Government”. But without enforcement of the current rules or patching the loopholes, the clinicaltrials.gov will keep generating undeserving negative news.
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