Clinicaltrials.gov has a Loophole that NIH and FDA Need to Close 
[Thursday, June 13, 2019]

Over the last two decades Clinicaltrials.gov has become an invaluable archive of all clinical trials where one can easily register a clinical trial, few questions asked; and that’s the problem. It has also become home to dubious and illegal clinical trials. There are trials pretending to be credible by virtue of being listed on a website maintained by the US government. Clinical trials fall into two broad categories – those that need pre-approval from FDA and IRBs such as those for the development of prescription products, and those that do not require formal approval from any regulatory body such as those for dietary supplements, and other unregulated products. An illegal trial is one that otherwise would require FDA and IRB approval, but is being done to take advantage of FDA’s enforcement discretion or simply pay-to-participate trial. The pay-to-participate trials are where patients pay to be included in a trial. These are plainly illegal as regulations do not allow sponsors to charge patients for enrollment in their trial. Similarly, enforcement discretion is a tool used by FDA to allow low risk clinical trials to continue despite being aware that these are not legal.  For a patient, it is hard to distinguish between legal and illegal trials. Patients trust the clinicaltrials.gov website, a clinical trial listed on the website is automatically believed to be legitimate. For the last few years, clinicaltrials.gov has carried disclaimers that the listing of a trial does not mean it is approved or even reviewed by the US government and that the responsibility for accuracy and compliance with the applicable laws resides with the submitters of the listing. But that sounds like a cop-out by the very agencies responsible for the accuracy of their website. It is about time NIH and FDA, who jointly share responsibility for the accuracy of information on clinicalstrials.gov, take steps to assure that only legitimate trials are listed on their website. And it is not hard to do. It can be done by making the questions regarding the regulation of the product by FDA to be mandatory, and by requiring the submitters to listing the names of the IRBs that reviewed the trial. And submitters of false information be treated as anyone who lies to the Federal agencies. This would also discourage non-US submitters who are much more prolific in illegally using clinicaltrials.gov than the US-based submitters. These simple measures can assure the patients about the legality of the listed trial and possibly prevent some of the deceptions.