Monday, 7 June 2021

Professional Patients are one of the Significant Challenges in Implementing Clinical Trials

COVID-19 has made clinical trials one of the most trending topics in the world in the past year or so. However, clinical trials have always been a crucial part of healthcare and virtually everyone’s lives since vaccines, medical devices, and processes originate from them.


A guest post by Salman Rashid

While everyone understands the importance of clinical trials now more than ever, their challenges are less talked about. In fact, one of the crucial but overlooked challenges in implementing clinical trials, professional study subjects, is notoriously low on the radar. But what are these professional patients, how common are they in clinical trials, and are they real or are they just a myth? Let’s dive deep into the topic of professional study subjects in clinical trials.



 

 

One of the crucial challenges while implementing clinical trials doesn’t receive the required attention

Starting from regulatory or compliance issues, site selection and planning, to not finding desirable patients, there are several challenges in implementing clinical trials. While these are often talked about while providing some useful tips to alleviate them, one challenge is massively understated - professional patients in clinical trials. To understand why they should be a significant concern, let’s look at what they actually are.


To put it simply, professional patients, or professional study subjects, are individuals who:

  • Attempt to enroll in multiple trials simultaneously or consecutively
  • Use dishonest means such as falsifying information to enroll
  • Do not care about skewing overall results as long as their needs are met


From that itself, it must be quite clear that they impose a significant threat to a number of things - their own safety, the safety of other participants, and the integrity of the trials they participate in.


Professional study subjects are quite real

Many might even think that these individuals do not exist anymore, but given the explosive growth of clinical trials and the compensation they might get by participating, these individuals do exist and resort to any means to participate. Let’s take a look at a few recent examples of professional patients participating in trials.

According to Medscape, there has been a number of cases where professional study subjects have attempted to participate in research studies and actually got in and out of them undetected. Most of these individuals participate by concealing or falsifying information such as their age, medication, etc. For most of them though, the main motivator is the money, while others are in it for the free treatment or the drugs (for recreational purposes), and the latter is quite dangerous. For instance, they lie about the effects of the agent in question just to receive more doses of it - the results can be quite disastrous.

There are even cases where honest participants have seen the presence of professional patients who participate using dishonest means. Since participating in trials can get a participant anywhere from $400 to a whopping $31,000, it’s not a surprise that it also attracts individuals who have nefarious intentions and use misinformation to enroll - making them one of the crucial but overlooked challenges in implementing clinical trials, as they turn up during recruitment.


Another case shows that they’re extremely common. After detecting some professional study subjects, Mr. Devine conducted a study that demonstrated at least 75% of the participants tried to enroll in other studies using misinformation to do so. They concealed health issues, medication details, and other relevant information.


These professional study subjects are more common in studies where the trials have to rely on self-reported symptoms and conditions that cannot be verified using objective screening such as depression, chronic pain, anxiety, schizophrenia, etc. The individuals simply might provide the required answers that demonstrate they are facing the condition(s) to get enrolled.

All in all, professional study subjects are a huge problem for clinical trials. 


Professional patients cause serious damage if not prevented

As previously touched upon, if professional patients in clinical trials are not prevented effectively, they cause a number of problems.

First of all, they hamper the integrity of trials - their participation skews overall results and might cause even the most promising agent to be delayed or unapproved entirely. This causes millions (or even billions) in losses. A clinical trial uses a considerable amount of resources, requires a few years, and a huge amount of investment - professional patients can let all of that go to waste.

Professional patients are a danger to themselves as well as to the other participants. The misinformation provided by them during the trial(s) is used to alter the dosage and might cause unwanted side effects.

Professional patients, as a result, must be prevented at all costs. Unfortunately, there is not much discussion regarding their presence as many might think that their participation might be insignificant, but as the aforementioned cases show, that is not the case.

 

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