A recent article in the Washington Post noted that ClinicalTrials.gov, which lists nearly 220,000 clinical studies in the United States and abroad, does not distinguish between trials that patients can enroll in for free, and trials requiring prospective participants to pay a fee.
The article cited the case of Linda Smith, an osteoarthritis sufferer who used ClinicalTrials.gov to find a stem cell therapy trial that she hoped could help her avoid knee surgery. During the screening process, she was told she would have to pay $14,000 to take part in the trial. Smith, a retired hospital administrator, told the Washington Post that she was “outraged” at the price tag and “disappointed in the NIH [National Institutes of Health]”, which runs ClinicalTrials.gov, for not requiring trial sponsors to disclose whether they charged patients to participate.
Rebecca Williams, the website’s assistant director, told the Washington Post that just because a study is listed “does not necessarily mean an endorsement by the federal government.” She explained that the NIH has no way to know whether a listing is essentially a for-profit study, and that it has no policy that would exclude such trials from ClinicalTrials.gov.
The article also quoted Paul Knoepfler, an associate professor at the University of California at Davis School of Medicine, who warned that:
Most people don’t realize that creeping into that database are some trials whose main goal is to generate profit.
The company sponsoring the trial, StemGenex, denied that it charges people for enrolling in its clinical studies and maintained that the cost involved was only for the treatment being tested. StemGenex’s website acknowledged that its procedures were not approved by the Food and Drug Administration.
According to the Washington Post:
Critics worry that some people seeking to participate in clinical trials may be desperately sick or in pain and vulnerable to requests for money they don’t have. These patients see the “.gov” domain and the NIH imprimatur as stamps of approval that mean the research is legitimate, they say. … [C]ritics would like to see NIH reevaluate its position on what studies are allowed to post on the website and what detail must be included.
The full article appeared in the Washington Post on 26th July 2016 and can be accessed here.