Patient-funded studies or pay-to-play clinical research are not brand new concepts, but they’ve been in the news recently in the context of stem cell treatments.
A recent paper by Leigh Turner, published in Regenerative Medicine, titled, “ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies” sheds light on the stem cell treatment clinics that register their “trials” on ClinicalTrials.gov to get free advertising, and ultimately charge patients very high fees to participate.
However, some patients don’t know that legitimate clinical trials almost never charge for participation, and even assume all trials listed on the site are government-approved.
Another story broke earlier this year that three patients had severe vision loss following injections, for which each paid $5,000, at a Sunrise stem cell clinic in Florida. Two said they found out about the clinic from its listing on ClinicalTrials.gov.
While it is a generally trusted site, there have been some questionable trials registered to ClinicalTrials.gov. Some critics even argue they shouldn’t qualify as real trials.
Exploitation of the ClinicalTrials.gov honor system
ClinicalTrials.gov is a valuable public resource and a collective good for many clinical research stakeholders. Turner believes it needs to be protected from parties willing to misuse and abuse it. He has found plenty of examples of what he identified as for-profit clinics claiming to offer “stem cell treatments” in the form of “stem cell studies,” using ClinicalTrials.gov as a marketing platform for their pay-to-play research.
As part of his study, Turner identified 18 studies across seven companies listed on ClinicalTrials.gov offering similar stem cell treatments that participants must pay to receive (and he believes there are many more less obvious examples he missed).
Some of the trials listed included keywords such as “patient-funded,” “patient-sponsored,” and “self-funded” studies. Others did not mention any payment on the ClinicalTrials.gov listing, but states payment in other sources. His investigation also found studies that were even less forthcoming and didn’t mention payment until the point of signing up for the trial.
[Related article: Clinical Trials Funded by… Patients?]
ClinicalTrials.gov does not require sponsors to disclose charges to patients and does not screen the listings that are added. It operates on the honor system. And just because the study is registered on the site, does not mean it is government-approved or -regulated. Yet, patients may not realize this because they are on a government website.
The NIH recently moved up a disclaimer to the top of the website that warns, “Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.”
Turner’s paper revealed that many of these stem cell studies have no record of peer-reviewed pre-clinical studies. Several of them also had inclusion/exclusion criteria targeting patient populations across multiple diseases that would lead to inconclusive or non-useful data.
Additionally, there was a lack of randomization, blinding and placebos incorporated into the protocol designs. Turner also found, where effective treatments exist and there is a standard of care that could be used as a point of comparison against investigational stem cell interventions, the trials he found on ClinicalTrials.gov cost significantly more.
There are several red flags Turner lists of unregulated stem cell clinical trials:
There are many issues with patient-funded clinical trials in general, from limiting who can participate based on affordability to amplifying the placebo effect. Patients should always consult with their doctor before enrolling in a clinical trial.
There remains a lack of clinical trial awareness among the general public and a need to help inform them of all options available, including those that won’t cost them thousands of dollars.
Legitimate clinical trials actively recruit study volunteers, and participation in the study is free of charge. In fact, most clinical trials offer stipends and/or reimbursements to participants for their inconvenience, time and travel costs to get to and from the study visit, rather than charge participants for experimental treatments.
[Related article: To Pay or Not to Pay: The Ethics of Participant Payments]
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