Patient-Funded Clinical Trials Are an Option for Patients
[Thursday, May 14, 2020]

Patients suffering from untreatable diseases could be helped by experimental treatments being evaluated in clinical trials. However, it is hard for most such patients to find well-matched clinical trials and to assure their enrollment in the same. What if the patient decides to fund a given clinical trial on themselves? Is it legal and is it ethical? There is no law prohibiting the participation of patients in trials that they support financially. There are numerous instances of patients individually or as a group raising funds to support the development of new therapies for their own disease. The most common way for patients to do that is by creating non-profit foundations that in turn fund research. The members of the foundation then get access to latest information on new therapies, fund the ones they find most promising, and participate as subjects in the ensuing trials. The patients also actively participate in regulatory processes such as FDA’s Patient Focused Drug Development (PFDD) initiatives, Advisory Committees, and even meeting FDA reviewers on behalf of the developers they support. So, there should be no ethical issues if an individual patient decides to do the above on his own. But it seems some ethicists don’t agree.  A report today in the New England Journal of Medicine of such a trial has created a debate on the ethics of a patient-funded trial. The study was conducted in compliance with all FDA regulations, with relevant IRB-approval, and by some of the most respected researchers in the country. And the research pointed out to the potential of the experimental therapy which would likely help many more patients with fewer resources than the one patient for the published study. This is a classical example of perceptions and practical conditions. The perception of a patient-funded trial is that it exploits the patient’s condition, but that argument could be made for any trial for an untreatable disease. Patients with untreatable diseases look at clinical trials as the last resort treatment option when all else has failed. Giving patients more say in the trial execution is fair and ethical. Every ethicist agrees that patients should be able to support experiments being conducted on them. So, supporting it financially should not be shamed. If a group of patients can do it, an individual should be able to do it also. The regulatory processes governing a conduct of a given trial should be allowed to do their job of assuring control of bias and scientific integrity. Patient-funded clinical trials are not only a viable option but also ethical and patient-centric one. It is about patient’s choice as to how much they want to be invested in a treatment, physically and financially. And no one but the patient should make that decision.