Professional study subjects in clinical trials is a concept that’s not widely known, unfortunately. However, the effects they have on clinical trials can be devastating, to say the least. Some of the other names they go by are “professional patients” and “duplicate subjects”. While pharmaceutical organizations, CROs, PIs, and the research team of clinical studies might be focusing on other challenges in medical research which they usually face, most of them might be unaware of the issues these duplicate subjects cause.
That being said, let’s take a look at what these professional study subjects actually are, some cases that show how they enroll in clinical studies, and what kind of damage they cause to clinical trials.
Professional study subjects in a nutshell
Professional study subjects have been around for a long time. While clinical trials date back to 500 B.C., professional patients are a much more recent discovery. But what are these professional patients or professional study subjects?
Professional patients in clinical trials are notorious individuals who, for various purposes, enroll in multiple clinical trials simultaneously or consecutively. These might be fake patients, i.e., faking their illness, or might also have the required conditions but are falsifying information during or before the trial. Whichever the case is, they use dishonest means to enroll in the trials and are one of the overlooked challenges in medical research.
With that out of the way, let’s take a look at some real-life stories of professional patients in clinical studies.
Tales that show how professional study subjects are overlooked challenges in medical research
The patient who lied in multiple trials
In the first of many stories, case, Ariana (pseudonym) participated in multiple clinical trials. While she had most of the conditions required for the first trial regarding asthma, she wasn’t entirely eligible because she had taken a steroid a few days before the trial. However, she still got enrolled – she lied about not having the steroid. Unfortunately, that’s just the start for Ariana.
In another trial about nasal polyps, Ariana wasn’t completely honest about her medication history. She saw that in the trial, one of the drugs being tested was the one she was actually using, and when asked whether she uses it or not, she simply stated “no” and get enrolled in the trial!
This just shows how professional patients enter into clinical trials, but there’s a bigger problem attached – more on that later. For now, let’s take a look at another professional patient.
The patient who lied for free treatment (and payments down the line)
Maria (pseudonym) is picky with the trials she participates in. However, one study she participated in provided free treatment using Botox. The second study she participated in included compensation, and it was the one where she started falsifying information.
She was asked whether she received Botox or not – she lied that she didn’t. She also lied about her age to get into the study.
Professional patients are rampant in studies that depend on self-reported cases
While the above were some tales about diseases that can be identified through medical screening, conditions such as anxiety, chronic pain, depression, schizophrenia, and other relevant diseases are difficult cases and researchers are mostly dependent on the symptoms reported by the patients.
In such cases, patients exaggerate their conditions to enroll into trials, and according to an expert, he has seen a professional study subject that went to enroll in at least seven sites within a year! When the patient was approached about the issue, they simply stated “You caught me!”.
This is not the only case – many patients go to such trials that depend on self-reported symptoms. These “professional patients” alter their medical history and their symptoms as per the requirements of the trials they want to participate in.
Professional study subjects threaten the outcomes of clinical trials
As can be clearly understood, these fraudsters are one of the crucial challenges in medical research. Their participation doesn’t only impact their own safety but puts other participating patients at risk. Moreover, their involvement threatens the integrity of clinical trials – they skew overall results and clinical research outcomes. Clinical trials can get halted, approvals can get delayed, and the trials might be shut down altogether due to professional patients – causing losses in billions and wasting a considerable amount of time and resources. As a result, professional patients in clinical trials must be prevented at all costs.
While there are solutions and strategies present to deal with the popular challenges in clinical trials, an obscure issue like the “professional patient” problem doesn’t have many solutions. Accurately identifying the patients during registration and subsequent visits can alleviate the issue significantly, especially if a shared database is used to blacklist known participants – saving billions of dollars in the process and ensuring the efficacy of clinical trials.
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.