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When it Comes to Clinical Trial Challenges, Professional Patients are a Real Headache

May 6, 2021/7004 views / 0 Comments/in BLOG, Clinical Trials, Data Integrity, Patient Data, Patient Identification, Patient Outcomes, Patient Safety, Professional Patients, Research /by Matt Gibson

“Professional patients”, “duplicate test subjects”, whichever term you want to give them, are exceptionally dangerous and are one of the understated clinical trial challenges. Not only are they a danger to themselves, but they also put other patients in the trial at risk. Moreover, their involvement threatens the integrity of the trial(s) – research results are skewed significantly and that can cause effective medicine to be unapproved by regulatory bodies, generating billions in losses.

RightPatient protects the integrity of clinical trials by preventing professional patients.

If you’ve been following our latest series of blog posts closely, you’d know what we’re talking about. Even if you’re not, that’s not a problem, because we’ll be covering more on professional patients in this article. Let’s take a closer look at how they get into the trials, some stats that show how common these duplicate subjects are, how helping them has become a job, and how they can be prevented from trials with positive patient identification using RightPatient.

Just another tale that shows one of the overlooked clinical trial challenges

In a previous article, we’ve talked about different tales of professional patients in clinical trials, why it’s difficult to detect them in specific cases, and how being vigilant might help in rare cases.

A PI who dug deeper after experiencing professional patients firsthand

The gist of it is that in the case of some trials, it’s virtually impossible to detect the severity of the conditions via objective medical tests. As a result, research teams have to rely on self-reporting of the symptoms, and in some cases, these reports are exaggerated by professional patients. A PI (principal investigator) even witnessed that a professional patient participated in around seven trials in twelve months! Another PI remained vigilant and noticed that the patients lied by looking at their medical records – let’s continue from this one.

A study on the involvement of professional patients in clinical trials was conducted by Eric Devine, Ph.D., and fellow researchers. Unfortunately, the results were quite frightening and far worse than imagined – something every sponsor, CRO, and PI must know about.

Some unnerving stats about professional patients

A whopping 75% of individuals falsified information just to participate in clinical trials, and they were involved in two or more studies just in a single year. The misinformation was regarding their health, medications, and the symptoms they faced. For instance, around 33% of them concealed medical problems, 20% concealed recreational drug use, whereas 28% concealed prescribed medications. That’s not all they uncovered – 14% of the sample falsified about having the required condition(s) whereas 25% of them overstated their symptoms to be a part of the trial(s).

RightPatient-prevents-one-of-the-overlooked-clinical-trial-challenges-professional-patients

Ensure accurate patient identification and prevent professional patients in clinical trials now.

Helping others get into trials using deceitful tactics is a profession now

A crucial discovery Dr. Devine and his team made was finding the existence of a research expert who specializes in helping professional patients get into clinical trials. This “kingpin” researched and attempted to get into the study that consisted of Dr. Devine and the team because the payment was quite high. After gaining knowledge about the trial and the right answers to the questions, the individual charged others $40 to share what they needed to say and do to get into the trials.

Moreover, some individuals take up clinical trial enrollment as a profession and even maintain sites that have relevant information such as trial locations, study criteria, enrollment status, and so on. In those forums, they casually talk about how professional patients can get into clinical trials, according to Dr. Devine. In fact, organizations that check for deception are flagged by the site’s moderators, and also advise which clinical trials to skip if the patients want to enroll in a way that violates study criteria.

Professional patients are one of the lesser-known clinical trial challenges

This is just one of the many stories of professional patients – there are far too many of these duplicate test subjects. While some of these bad actors are discovered, others, unfortunately, make it through the trials undetected, something that is far more dangerous.

As mentioned at the beginning, not only does the presence of these bad actors put their safety in jeopardy, but it also threatens the integrity of the trials they participate in, leading to skewed results, halted or canceled trials, and billions in losses.

A potential solution to prevent duplicate study subjects

In a nutshell, professional patients must be prevented from participating. One of the most ideal ways to do so is by creating a centralized identity clearinghouse for clinical trial patients and ensure that the duplicate subjects are red-flagged whenever they try to enroll in a trial.

Fortunately, RightPatient can help with that. A touchless biometric patient identification platform used by several leading U.S. healthcare providers, RightPatient has the experience and capabilities to prevent professional patients in clinical trials.

Contact us now to know how we can help you protect the integrity of your clinical trials and prevent delays in approvals by eliminating a crucial problem – saving millions in the process and improving the efficacy of your studies.

Duplicate Subjects in Clinical Trials Are an Overlooked Pain Point – But They Can Be Stopped

May 5, 2021/7277 views / 0 Comments/in BLOG, Clinical Trials, Data Integrity, Patient Data, Patient Identification, Patient Safety, Professional Patients, Research /by Matt Gibson

We’ve been talking about duplicate subjects in clinical trials for quite some time now. That’s because they continue to exist in significant numbers, and, contrary to popular belief, these individuals DO hamper clinical trials in one way or another. While the impact on different clinical trials varies due to their involvement, the worst-case scenario is that the affected trial shuts down due to skewed research outcomes. As a result, promising medicine, medical procedure(s), or device(s) don’t see the light of day due to these fraudsters. That being said, let’s take a look at more real-life cases of professional patients and how a robust patient identity management platform can prevent their participation in clinical trials.

Prevent professional patients in clinical trials with RightPatient.

A few more cases of duplicate subjects in clinical trials

While we’ve seen a few cases where professional patients participated in clinical trials for the money or the free treatment involved, let’s take a look at a different case that shows why it is difficult to detect these fraudulent participants during enrollment – the case of patient Z.

Exaggerated, self-reported conditions lead to duplicate subjects in clinical trials

Those who are familiar with clinical trials know that potential study subjects or patients are vetted thoroughly before enrollment. For those who don’t know, in a nutshell, background checks are conducted, their physical conditions are screened to identify whether they are ideal for the trial via various medical tests, and interviews are conducted to identify any unwanted traits.

While these tests usually do identify any anomalies, they cannot identify conditions such as depression, anxiety, and even chronic pain, among other relevant diseases. Unfortunately, there are no objective medical tests (as of yet) that can determine whether a patient has any of the aforementioned conditions or not, only self-report screening instruments. As a result, exaggeration by professional patients regarding their condition(s) can get them enrolled in clinical trials, and that’s exactly the story of patient Z.

According to Dr. Thomas Shiovitz, he saw the peculiar case of a duplicate subject who actually went to seven sites within 12 months! Dr. Shiovitz states that he detected the patient in seven trials – however, the patient may have gone to more sites without being detected. Unfortunately, some of these studies were being conducted simultaneously, thus, the patient adversely affected most of their results.

When finally caught regarding his nefarious activities, the patient simply exclaimed “You caught me!”

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RightPatient prevents duplicate test subjects in clinical trials.

Some cases might be caught if the PIs remain vigilant

According to Eric Devine, Ph.D., he had somewhat of a similar experience. While conducting clinical trials or when talking to the patients, he witnessed a number of them who kept lying about one thing or another related to their medical conditions or identities. How did Dr. Devine detect the lies? It’s quite simple – he glanced at their medical records. There were even cases where he would recall a professional patient who came in with a different identity earlier – they were just desperate to participate in the trial. And this was not an isolated incident, Dr. Devine witnessed that many people utilized the same tactics to get into one of the clinical trials. This is exactly why we keep saying that duplicate subjects in clinical trials still exist, and in considerable numbers.

Therefore, after finding these fraudulent individuals, Dr. Devine tried to ensure that no more duplicate subjects were involved in his trials as they not only invite danger for themselves but also threaten the integrity of the trials.

Thankfully, RightPatient can remove the burden of detecting professional patients in clinical trials manually for Dr. Devine and for anyone who wants to ensure the efficacy of their clinical trials.

RightPatient prevents duplicate subjects in clinical trials

RightPatient has been helping leading U.S. healthcare providers prevent scammers from assuming their patients’ identities. It is a touchless biometric patient identification platform that prevents medical identity theft within healthcare facilities and at any touchpoint across the care continuum.

RightPatient identifies patients using their photos, and during enrollment, attaches them to their medical records. For subsequent visits, patients only need to look at the camera – RightPatient locates the accurate medical record after searching for a match.

Since it’s already tried and tested to prevent fraudulent individuals, it can do the same for clinical trials as well and prevent professional patients in clinical trials – saving them millions, ensuring the efficacy of the studies, and ensuring the safety of the subjects involved.

The Professional Patient Problem Still Exists in Clinical Trials – Are You Preventing Them?

May 2, 2021/5972 views / 0 Comments/in BLOG, Clinical Trials, Data Integrity, Patient Identification, Professional Patients, Research /by Matt Gibson

We’ve been talking about clinical trials for some time now. Usually, we talk about how integral these studies are for discovering new drugs, devices, or treatments, and how their outcomes affect all our lives as well as healthcare in general. However, today we are focused on one of the overlooked issues – the professional patient problem, and how the long-standing issue continues to skew overall results.

That being said, let’s take a look at a real-life case of a professional patient that participated in multiple clinical trials, how their involvement and actions can hamper trials and cause billions in losses, and how a patient identity verification platform like RightPatient can help prevent their participation.

RightPatient can prevent professional patients in clinical trials.

The professional patient problem is very real – a recent example

A case that occurred in 2019 in Louisiana

At the end of 2019, patient X had signed up for a clinical study for asthma. While she was accepted into the trial like most of the individuals that volunteered for it, she had falsified some of her information to make herself appear eligible for the trial.

There was a prerequisite stating that the subjects shouldn’t have had a certain steroid within the past two to three weeks. However, patient X did take it only a few days before signing up for the trial, and when she was asked, she flat-out denied taking it, as per Medscape Medical news. Unfortunately, she did make it into the trial, and her statement regarding her use of the steroid wasn’t verified.

However, that was just one clinical trial patient X participated in – there’s more. Otherwise, this wouldn’t have been an example of the professional patient problem!

Same professional patient, different study

Patient X participated in an entirely different study on nasal polyps, and in this case, she once again provided misleading information. While the trial focused on reducing nasal polyps using a certain spray, patient X was already using the same medication, but she informed the officials that she wasn’t. The study compensated her handsomely, which is why she was tempted to falsify information.

But what did the officials do to verify her information?

They requested a note from her physician, checked her driver’s license, required access to her patient portal, and viewed photos of her medications, among other things. Even then, they couldn’t detect the fact that she falsified information to sign up for the clinical trial.

Professional patients skew overall results and delay effective trials

The tale of patient X is not a rare incident, unfortunately. These cases are examples of the professional patient problem, and they occur too often to be ignored. The participation of these individuals is a significant blockage to carrying out clinical trials effectively, and more often than not, these cases are discovered only when it’s too late. Their involvement in the trials affects data significantly and might cause even promising drugs to be delayed or even announced to be ineffective. Not only does their participation cause promising drugs to not see the light of day, but it also causes much-needed breakthroughs in medicine to be delayed. These are the consequences of professional patients falsifying data, participating in multiple trials simultaneously or consecutively, and faking results, and might cause trials to not proceed to the subsequent phase(s). As a result, the participation of professional patients, or “professional study subjects”, must be eliminated.

Fortunately, professional patients in clinical trials can be prevented with RightPatient.

RightPatient helps combat the professional patient problem

A touchless biometric patient identification platform, RightPatient has been helping responsible healthcare providers prevent scammers from using healthcare services within their facilities. The platform identifies patients using their photos that are taken during registration and prevents fraudsters from assuming the identities of registered patients – it can do the same for clinical trials too.

RightPatient can help maintain a database of the registered patients in clinical trials at multiple sites, and whenever a fraudster or these professional patients try to sign up, the platform can red-flag them – saving billions, protecting the integrity of your trials, and preventing delays.

Use RightPatient now to see how it can ensure that your investments are protected and improve the efficacy of your clinical trial(s).