Contributed Commentary by Salman Rashid

June 22, 2021 | Clinical trials is a trending topic due to COVID-19, which has abruptly upended our lives for the past year or so. Even now, a lot of people think that clinical trials are recent discoveries, but we know that the reality is much different. Clinical trials have an ancient history—the earliest ones can be traced back to biblical descriptions in 500 B.C! Now, many people are concerned about how quickly the COVID vaccines were developed, how safe they are, etc. Healthcare professionals, on the other hand, have always been concerned about clinical trials.

There are many obstacles that CROs, researchers, investigators, and pharmaceutical companies face before and during their research studies, and overcoming them is crucial to ensuring that the trials are conducted reliably. However, one challenge is often ignored: duplicate subjects in clinical trials. These individuals go by many names: “professional patients”, “professional study subjects”, and “duplicate subjects”, to name a few. However, their involvement and unscrupulous behavior greatly threaten the integrity of clinical trials (more on that later).

For now, let’s take a look at a few examples of some duplicate subjects in clinical trials, the reasons behind their actions, and how they hamper research outcomes.

Dishonest Patients

According to Medscape, cases show how easy it is for many subjects to enroll into trials in ways that violate rules and regulations. Let’s take a look at their stories. (Note: all of the names mentioned within the article are fictitious while the stories are unaltered)

Lying is quite common to enroll in studies. In 2019, Julianne successfully enrolled in a clinical study conducted on asthma, just like the rest of the patients. However, unlike the other approved patients, she was ineligible for the trial and falsified her information to enroll.

To qualify for the trial, one of the requirements was that subjects must not have taken “prednisone steroids” in the past two to three weeks. In Julianne’s case, she did take this medication a few days prior to the study, but she concealed this piece of crucial information. The lie wasn’t detected and she was able to enroll in the trial.

Unfortunately, this wasn’t the only time Julianne lied to participate in a clinical trial.

She participated in another study, this time on allergies and nasal polyps. In this case, Julianne concealed her medication history. The study in question observed how different sprays would affect nasal polyps. Coincidentally, the brand they were testing was actually the one being used by Julianne herself! However, she failed to mention it when asked.

The research team checked her driver’s license, photos of her medications, and wanted to access her health portal. Julianne experienced that smaller lies, like hiding one’s age or medication, were easy to perpetuate. However, she might not know that there are many cases where patients exaggerate their conditions to get enrolled. These are common in research regarding anxiety, depression, schizophrenia, and similar conditions.

These are just two cases of Julianne falsifying her information to successfully participate in clinical studies. Given the chance, who knows how many more times she’ll enroll?

Other patients enroll for free treatment and compensation. Annabelle, another professional patient, has lied to gain access to multiple clinical trials. Over a five-year period, she successfully enrolled in three studies. The first one, focusing on “botulinum toxin” (Botox), didn’t provide payment but offered free treatment.

The second study that Annabelle participated in was also about botulinum toxin. One of the screening questions was whether or not she ever had Botox. A “yes” answer would have triggered her exclusion, so she replied “no,” despite the fact that she had received it in the previous trial. She also fudged her age and got away with it.

While Julianne and Annabelle falsified information to gain access to trials, they believed that they were contributing to medical research by participating. As it turns out, this is a very naive perspective since their involvement can have a substantial impact on overall trial results. Research for promising drugs, procedures, or medical devices is often halted prematurely or fails to make it past the initial phase when duplicate subjects participate in clinical trials.

Professional Patients

The problem of professional patients is so prevalent that even rule-abiding patients have stories to tell. For example, Matthew has always participated in clinical trials without resorting to dishonest means. However, while he never falsified his information, he met a few people who certainly did. According to Matthew, these people believe that rules don’t apply to them, so they simply lie without hesitation. This just goes to show that even normal study subjects are aware of these bad actors.

For Matthew, clinical trials are a key source of income. One trial earned him over $30,000, and herein lies one of the biggest motivators for professional patients. As for Matthew, he’s in it for both the financial aspect and a sense of being useful; he participates in Alzheimer’s studies because his grandmother suffers from it, unfortunately.

Professional patients, or duplicate test subjects, have been in the news infrequently, and for good reason. While there have been studies and strategies about reducing their participation, the aforementioned cases show that bad actors do make it through and end up participating in clinical trials. Even one of them is enough to skew overall results and reduce the efficacy of trials or studies.

As you may have guessed, most patients participate in trials for the money—compensation can range from $400 to around $30,000! Others participate in trials for the free treatment. The rest of them don’t want the cure or the money; they just want the drugs for recreation (these mostly occur in addiction studies).

Whatever the reason, participating in clinical trials or studies through dishonest means is dangerous for patients that are receiving experimental drugs and significantly hampers the data integrity of all trials in which they’re involved. As a result, even if the drugs were promising, they never see the light of day due to undesirable results. These events also cause billions of dollars in loss for pharmaceutical companies. And who knows, we may have had breakthroughs in medicine much earlier than we usually do!

While there are various ways to approach the “professional patient” problem, one of the best ways to eliminate their participation is by using a robust and centralized biometric patient identification platform. This can help to blacklist professional participants in clinical trials, protect the integrity of trial data, and save pharmaceutical companies and their CROs a ton of money in the process.

Salman Rashid is a Digital Marketing Analyst at RightPatient, a patient identification platform used by many healthcare providers that can prevent professional patients. He is an avid reader, is passionate about tech, and regularly writes on topics such as patient safety, compliance issues, and healthcare IT. He can be reached at salman@rightpatient.com.