Legitimacy of Clinical Trials

To determine the authenticity of any treatment, therapy or procedure, people refer to clinical trials. Study findings enable us to identify the success rate and evaluate its legitimacy. But are all clinical trials truly legitimate? It’s unfortunate but true that only a few are authentic while others are questionable. 

Let’s put things in perspective to understand it better.

According to scientific bodies in the field of eye research, clinical trials related to stem cell treatments have increased with time much of which is owed to the fact that it is the most inquired treatment by AMD patients. And why not; after all, it is being considered as a break-through in eye disease treatment as in some research studies, stem cell treatment has produced interesting results. But it is still too early to judge and confirm that it is as safe and effective as we think it is. 

At present, stem cell treatment research is in its infancy stage and is still being tested for safety. Rigorous studies and clinical trials must be conducted for several more years to come before the success of this treatment can actually be proven. Now you must be wondering that when a research study for an eye disease is listed on the ClinicalTrials.gov website, does it means that the trial has been approved? Well, that’s what many people assume but in real, that’s not true. If a study is listed on ClinicalTrials.gov it doesn’t necessarily mean that it is approved by the FDA or the NIH. And if you are thinking of participating in such trials, you must first consult your physician.

Many people assume that if it is a government website, it is trustworthy and a reliable source of information. But you must know that not all trials listed are authentic. According to the University of Minnesota bioethicist Leigh Turner, some businesses are just using their registry with ClinicalTrials.gov to promote the intervention of a stem cell treatment. Simply put, these businesses are repurposing ClinicalTrials.gov as a PR and marketing tool to gain popularity and promote unproven stem cell products into the market. And like it or not, this act is extremely dangerous.

Watch Out for Pay-to-Participate Clinical Trials

One of the best ways to determine whether or not the trial that you are thinking of participating is legitimate is to see if the sponsor of the trial requests for payment from the patient for trial participation. Pay-to-Participate is a red flag. Such trials raise numerous ethical issues like unfavorable risk to benefit ratio and lack of equal participation opportunity. 

Patient funded studies are biased. By listing studies on government websites, businesses selling interventions for stem cell treatment look authentic and genuine as they are able to solicit prospective clients.

There are numerous reports published and have made the headlines showing how patients who participated in such studies have suffered from severe vision loss even after paying thousands of dollars to sponsors for stem cell interventions.

To sum up, here we would like to state that don’t just participate in studies. Think through before you take any such step. It is advisable that you validate the authenticity of the sponsor, the trial, and avoid participating in research studies that are pay-to-participate.