Patient-Funded Clinical Trials Raise Concerns

Ethicists worried trials will threaten scientific rigor and efficacy.

With web sites like Kickstarter and Go Fund Me exploding in popularity, concerns have been raised recently regarding the notion of patients funding their own clinical trials.

A column recently published in Cell Stem Cell by Carnegie Mellon University (CMU) ethicists noted that patient-funded trials can potentially threaten scientific rigor, relevance, efficiency, and fairness instead of involving more patients in research.

"Patient-funded trials look like they could be a boon to science by attracting previously untapped resources to research," said lead author Danielle Wenner, assistant professor of philosophy CMU. "The problem with this model is that it lacks mechanisms to ensure that research is grounded in good science. Rather than increasing the pace of biomedical progress, it may delay innovation through the diversion of resources, and ultimately harm the very people it is intended to help."

The researchers stated that in light of limited funding available from the National Institutes of Health and other agencies crowdfunding trials are growing more popular as people seek alternate funding methods.

"Patients with diseases that do not have effective treatments and interventions are desperate to see the pace of science move more quickly or get fast access to something that will help them immediately. Similarly, researchers who can't get NIH funding are turning to crowdfunding," said Alex John London, professor of philosophy and director of the CMU Center for Ethics and Policy.

The authors noted that patient-funded trials appeal to seriously ill patients who are more willing to take risks. Additionally, these trials can lead to clinics that are more motivated by profit than providing new interventions that may lack sufficient basic scientific findings to support it.

"Many patients and patient advocacy groups think the current funding system is too conservative," London said. "But, it's a system that directs the individual interests of various parties toward one goal. For example, drug companies can't make money until their intervention passes requirements set by the FDA to ensure that it actually works. Patient-funding trials sidestep such mechanisms."

To better align patient-funded trials and clinics with sound research, the authors suggest offering incentives through large-scale policies. This approach could offer scientific and ethical oversight via mandates from a wide range of stakeholders, including academic medical centers that require peer review of all research trials.

Another potential incentive includes accreditation requirements for health care facilities that encourage the use of appropriate scientific review methods and ethical considerations.

"The bottom line is that patient-funded models are a novel funding model, but they threaten to de-stabilize a system that ensures high quality results," London concluded.