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Current Challenges in Clinical Research that Hamper Trials

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Clinical trials have existed for a long time but they became even more important when COVID-19 raged. Traditionally, all vaccines, medical devices, and beneficial drugs designed for specific diseases are created by carrying out intensive tests to ascertain their safety and viability in treating the disease through clinical trials. The process of a clinical trial can be excruciatingly long and laborious with several factors that could deter its progress and success. We will discuss the notable challenges common to clinical research, how it affects the process and the results of clinical trials, how sponsors and Principal Investigators (PIs) leave crucial issues out unsorted, and how to best take advantage of patient identity verification.

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Preventing professional patients is possible with RightPatient.

Current challenges in clinical research 

Arduous, dangerous, time-intensive, and complex are the words that can fully capture the nature of the process that surrounds clinical trials. The trial is supervised by Sponsors and PIs to ensure that there are no violations of the rules and regulations to the letter such as the enrollment of the right amount of patients that fit the required conditions for the trials. They are also tasked with the stringent management of several trial sites. Here are some of the challenges that oppose the success of clinical trials.

Patient recruitment can pose a huge challenge

The most recurrent aspect in the list of current challenges in clinical research that often occurs right from the conception of the idea of a clinical trial is the issue of patient recruitment. Some of the problems, in this case, include the unresponsiveness of patients, the attraction of patients with conditions that do not fit the subject of the test, or poorly performing research sites. These could end the clinical trial before it even starts. If we are to delve into the lengthy list of the challenges of patient recruitment, it would take an entirely different article of its own.

The focus here is that there can be no clinical trial if test subjects are not available or they do not fit the criteria for the trial. The problems that may arise from the trials may result from the fact that research data was not enough to affirm the drug/vaccine’s effectiveness. Irrespective of the promising nature of the agent, the drug may fail to progress to the subsequent phases necessary for approval for general use.

Designing trials that ensure success

The process of designing a successful clinical trial is also one of the top challenges because it has to satisfy everyone. At the start, it was not so complex, all rules and regulations were often in their infancy, and things were always pretty easy.

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Current challenges in clinical trials – RightPatient addresses the overlooked one.

Modern clinical trials, however, have taken on a new shape of complexity with rules that must be adhered to from top to bottom. It must be simple for patients to understand and obey, it must proffer answers to rather difficult questions in the right way, and ultimately, it must satisfy the necessary stakeholders. Meeting expectations in a trial design is not easy. This makes it one of the most consistent of the current challenges in clinical research.

Ensuring and maintaining compliance with the rules and regulations

The healthcare industry is a highly monitored sector because of the gravity of the healthcare outcomes of patients in the system. The subsequent products of clinical trials such as drugs, vaccines, treatment processes, and medical devices represent outcomes, they are also subject to heavy regulations.

The existence and importance of the regulations are relateable but it also makes for a herculean task in strict compliance. The slightest discrepancy could hinder the trial and lead to a huge financial loss running up to millions. Maintaining and ensuring compliance remains a great challenge with unlimited imposed regulations.

Preventing professional patients

Professional patients is not a commonly discussed term whenever issues related to current challenges in clinical research are raised. Nonetheless, it is also a crucial issue. It goes by different terms like “professional study subjects” and “duplicate study subjects”, and they are individuals who are capable of thwarting the credibility of clinical trials. They are culpable for participating in multiple trials simultaneously or consecutively, thereby influencing ruining the overall results of the trials that follow.

A relevant illustration is that of a duplicate study subject that has been diagnosed with a heart condition and has participated in a trial and received dosages of an experimental drug. The subject then goes almost immediately to partake in another trial. The problem lies in the fact that the initial drug is still in their system and it will project wrongly on the second trial. There is also the danger attached to going to multiple trials as it will not only skew the results of the trials but will also be harmful to them.

These types of patients affect the integrity of clinical trials while also presenting a danger to their health. In addition, they could lead to losses worth millions and can lead to experimental agents being deemed as failures because of skewed results. Fortunately, RightPatient can prevent

If you are looking for the right tool to help in dealing with professional patients in clinical trials, you can count on RightPatient. It is a trusted touchless patient identification platform that has earned great reviews from top healthcare providers. It has ample capabilities and experience that could put an end to issues of professional patients effectively. The platform could help to save millions worth of losses, and mitigate delays in approvals, and enhancing the integrity of trials. RightPatient is the perfect way to prevent professional study subjects in clinical trials.

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How Professional Patients are One of the Crucial Challenges of Clinical Trials

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Clinical trials have been around for years. They’re often a way of testing new treatments on people who are already requiring treatment for something. For those with terminal diagnoses, they may prolong life or improve the quality of their remaining time. Chronic conditions may be alleviated, and treatment once considered experimental and new may become mainstream after a successful clinical trial. They might allow the development of new drugs or instead, look at prevention or better diagnosis of disease. Clinical trials can help establish whether screening, imaging, or testing can assist early diagnosis or investigate how best to support those people diagnosed with a particular disease. However, all of these can be damaged by the challenges of clinical trials, and one of the overlooked ones is professional study subjects – let’s see how.

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Clinical trials attract different types of individuals

For some, a clinical trial can simply be a way of getting a free treatment or being paid for the time the trial takes. Some patients will use any underhand means at their disposal to ensure their place on these trials, as for them, they are lucrative little earners. So many people are living with multiple illnesses that simply paying for all the medications can get expensive. Any chance that they find to try something for free is a lucky break for their finances. Then, many individuals are more altruistic. They simply want the chance to take part in something which might potentially change the course of treatment for other patients, some of whom may be their loved ones.

So, it was with the trials of the COVID-19 vaccines. The light at the end of the pandemic tunnel; a chance to gain a measure of protection against this virulent disease. Some people, however, were purely in the trials for their own ends. They wanted the vaccine first, both doses, and they would stop at nothing to get it – the majority of the trials face these types of individuals.

So how could these professional study subjects play the system like this and become one of the overlooked challenges of clinical trials? Lax patient identification is not the only answer, it’s far more complicated than that. 

  • One way these professional study subjects game the system is to ignore the terms and conditions of the trial. They maintain they meet the criteria, when in fact they have an underlying condition that would automatically exclude them from taking part. Or they choose not to disclose that they are already participating in another trial when the rules of the second trial they are applying for clearly state that it must be the only trial they are enrolled in at any time.
  • Earning money may not be the sole motivator for everyone. Some people like to take advantage of freebies to save money on their medical bills. Others could have more nefarious reasons, like acquiring the drugs for recreational purposes. There is also a group of professional patients who hope the medicine or treatment being trialed will stop or slow down their disease, even if that’s not the prime reason for the trial. These patients are more likely to travel long distances to ensure they are in the group testing the new treatment, rather than receiving a placebo. They may also enroll in multiple sites under different identities. This has the potential to skew the results of the trial, which could affect the chances of a treatment being brought to the market.

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  • Assuming a false identity is the way many of these professional patients get around the rules on participating in clinical trials. If they look alike, they could masquerade as their sibling, or simply purchase a forged identity online for a fraction of the money they stand to earn from the trial. For those who know where to look, fake documents are available for $50 to $100, and the earnings from a trial could run into thousands of dollars for each participant.
  • These professional patients are willing to game the system in any way possible. Even falsifying participation is not unknown – saying they took the drugs when they haven’t. That means they won’t show any effects, although they will still be treated as a trial member. If enough people on one trial game the system in various ways, the results could be irretrievably altered, and the rollout could be delayed or halted, no matter how promising the previous work had looked.

RightPatient prevents professional patients

Using a touchless biometric patient identification platform like RightPatient can prevent one of the overlooked but crucial challenges of clinical trials. It can detect blacklisted participants who try to use the trial to their own ends – eliminating professional patients in clinical trials. This increases the integrity of the trial and ultimately improves results. Because it allows accurate recording of someone’s participation in the trial, it prevents fraud, wasted effort, and delayed approvals – saving millions in the process and preventing trials from being shut down.

Clinical trials can benefit from using the RightPatient platform to correctly identify their trial participants. The trials will have accurate data, and the patients’ records will be correctly updated with their participation and the outcome.

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Professional Patients Are One of the Overlooked Issues in Modern Clinical Trials

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Clinical trials and professional patients – we’ve been talking about them for quite some time now and how fraudsters are one of the overlooked issues in modern clinical trials. While most enrolled patients are strongly vetted and their backgrounds are thoroughly checked, we’ve already seen many times that the information they provide isn’t always accurate and how these fraudsters slip through the cracks and make it into the trials. However, we’ve got more stories that demonstrate how professional patients exist in trials.

That being said, let’s take a look at a few more studies regarding professional patients and how ensuring positive patient identification can prevent duplicate test subjects in clinical trials.

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Modern clinical trials are vulnerable to professional patients.

Stories from an expert about one of the critical issues in modern clinical trials

COO of Verified Clinical Trials, Kerri Weingard, stated that out of all the patients that apply to participate in U.S. trials, those who falsify information or violate criteria range between 14% – 25%.

How do they qualify?

Most of these fraudulent applicants’ actions are quite similar to those of professional patients. According to Ms. Weingard, a few of these individuals enroll in studies for specific diseases and even tamper with their medical history to participate in other trials either subsequently or simultaneously. Some claim that they have conditions in one trial, and they don’t have them in others! Quite a simple example would be a person who enrolls in a trial for heart disease and says that they have the condition. After enrolling successfully and completing the trial, they will alter their medical history and enroll in another study claiming that they have no medical conditions.

Ms. Weingard also says that this is most common with CNS (central nervous system) trials. For instance, diseases such as panic disorder, anxiety, schizophrenia, bipolar disorder, and depression cannot be detected objectively – research teams have to rely on the symptoms reported or demonstrated by the patients. Professional patients take advantage of this and exaggerate or falsify their symptoms to enroll in the trial. Moreover, as many of them are in it for the money, they go to other trials and state that they don’t have such symptoms. All in all, their symptoms are dependent on the requirements of the trial and they have the ability to pull off the deception in many cases.

More numbers that show duplicate study subjects

Ms. Weingard also presented a study at the American Society of Clinical Psychopharmacology meeting – it focused on professional patients, was conducted for three years, and included 113 CNS trials. The total population was exactly 10,092 individuals and there were 498 inclusion or exclusion protocol violations, out of which 91 violated the washout period, 45 tried to qualify for an entirely different study at the same site and 25 at other sites, and 42 were red-flagged for trying to “dual enroll” in more than one study simultaneously.

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Eliminate the participation of professional patients in clinical trials.

One thing is pretty clear – professional study subjects are one of the crucial issues in modern clinical trials, and a robust solution is needed to prevent them. One of the feasible ways is ensuring accurate patient identification with RightPatient – more on that later.

Another study states professional patients are a headache!

Dr. Thomas Shiovitz and his team conducted a study to determine the magnitude of the “professional patient” issue, and its title uses humor to express that professional patients are a headache in migraine trials.

Out of 2192 subjects who applied for the trials, around 19% attempted to register in a different site within 18 months. From this group, 24% of the subjects attempted to enroll in a different migraine trial and the rest of them (76%) tried to enroll in studies involving schizophrenia, depression, or even as healthy test subjects. 

While many agree that some professional patients are dangerous, they argue that others are naive and don’t know the rules and regulations about participating in such trials. For instance, they’re provided with endless pages of terms and conditions, and many of them don’t even read the entire document before they sign up. As a result, they don’t know how they might affect other trials if they enroll in the subsequent ones consecutively or simultaneously. This is perhaps one of the reasons why professional patients are one of the ignored issues in modern clinical trials.

However, regardless of the different perspectives, professional study subjects do harm the efficacy of clinical trials and might cause them to be halted, delayed, or even prevent them from proceeding to the subsequent phases because research results are skewed and contain inaccurate information.

RightPatient prevents one of the critical issues of modern clinical trials

The participation of professional patients in clinical trials must be prevented at all costs – something our touchless patient identification platform can achieve efficiently. 

RightPatient is the definitive patient identification platform used by responsible U.S. healthcare providers – it red flags fraudsters when they attempt to access care unlawfully. The platform can prevent professional patients in clinical trials as well. A patient won’t be able to enroll in the same trial twice, and if the information is shared across sites, they will be red-flagged when they try to enroll in the other sites.

Contact us now to learn more about how RightPatient can help protect the integrity of your trials effectively and efficiently.

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

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“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.

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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).

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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.

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

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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.

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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. 

Contact us now to learn how we can help you improve the integrity of your clinical trials.

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Professional Patients Are One of the Overlooked Clinical Trial Issues – More Examples

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If you google the term “clinical trials” right now, you’ll see that virtually everyone is talking about them and are extremely interested in the topic. That’s because the pandemic has thrust the topic into the limelight, leading to even the average person talking about clinical trials. While most of the world is interested in clinical trials to learn about the vaccines that can combat the infamous virus, we’re here to talk about the efficacy and integrity of such studies. We’ve already covered how and why “professional patients” or “professional study subjects” are one of the less-discussed clinical trial issues. Today, let’s explore a few more real-life cases that support our claim and how effective patient identity management with RightPatient can prevent the participation of professional patients.

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Professional patients in clinical trials are one of the less-discussed issues.

Some examples to confirm professional patients are one of the hidden clinical trial issues

We’ve already talked about a case of a professional patient who falsified their information and participated in a few clinical trials. While the patient was in it for the money, let’s take a look at some other real-life cases.

A tale of lies

Patient Y had also participated in multiple clinical trials – three, to be precise, in a span of five years. According to her, these trials are short-term opportunities, and she turns down the ones that involve testing unproven drugs on her. The initial trial she participated in involved the use of a certain “botulinum toxin”, and while there wasn’t any payment involved, she got the treatment for free. 

The next trial patient Y participated in was about the study of the same toxin, and the research team took her blood sample, conducted an ECG, as well as other tests. This time, she did receive financial benefits – one of the incentives she searches for in trials. However, she provided incorrect information this time around – she decreased her age as well as lied when asked if she got Botox earlier or not (she did receive it in the first trial). She chose to get into the trial because she was getting paid and because she was getting free Botox. 

One glaring issue here is that even though the officials could have easily checked patient Y’s documents to verify her age, they didn’t, and she got to participate in the trial. This shows that not everyone who signs up as a participant is vetted thoroughly, which is why a robust patient identification solution is required – more on that later. Moreover, even though these professional patients are falsifying information to get into the trials, many of them believe that they are contributing to the medical community by being participants. Unfortunately, that is far from the truth, as they are part of one of the overlooked but crucial clinical trial issues that threaten the integrity of the studies.

Even regular test subjects know a few professional patients!

This case is different, as the patient involved, Z, never used any unlawful means to participate in trials, and even though he participated in some trials, he did so by complying with the rules and regulations.

However, patient Z did meet a number of patients who used misinformation and other means to participate in the trials, and according to him, they believe that the rules do not apply to them.

While patient Z participated for the financial benefits as well as helping advance medicine, he complied with all the rules and regulations. He used the compensation he received to pay off debts as well as support himself for around ten years – one of the trials that focused on Alzheimer’s paid him $31,000.

Moreover, as his grandmother has Alzheimer’s, patient Z feels that by participating in clinical trials to advance medicine that might be of use to her one day, he’s helping her.

“Professional patients” continue to be one of the overlooked clinical trial issues

As the above examples show, “professional patients”, “professional study subjects”, or “duplicate subjects”, whichever term use, still exist in clinical trials. They falsify information such as their age, identity, medical history, etc. to enroll in multiple trials simultaneously or consecutively. Doing so not only hampers their health and safety, but the safety of the other patients involved in the trials.

To make matters worse, their involvement skews the overall results of the research, leading to delaying the trials or even shutting them down due to undesirable but inaccurate information. Professional patients cause billions of dollars in losses, can lead to delayed approvals from regulatory agencies, and lead to wasted years of effort from sponsors, research teams, and CROs. These individuals must be eliminated from clinical trials right from the start – RightPatient can help with that.

Use RightPatient to prevent one of the overlooked clinical trial issues

RightPatient is a tried and tested solution in the U.S. – several healthcare providers are protecting millions of patients with it. It is a touchless biometric patient identification platform that uses patients’ photos to identify them accurately across the care continuum, and the same concept can be used for clinical trials. 

RightPatient can prevent the participation of professional patients in clinical trials by red-flagging individuals attempting to participate in either multiple trials or at different sites of the same trial. It helps improve the efficacy of clinical trials, remove any unwanted individuals that can skew the overall results, and protect the integrity of these trials.

Contact us now to learn how we can help protect your clinical trials from skewed results with our robust patient identification solution.

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

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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.

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. 

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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).

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4 Common Challenges in Clinical Trials – How Are You Addressing Them?

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We’ve talked at length about the challenges in hospitals, health systems, telehealth, and other aspects of the U.S. healthcare system. Today, let’s take a step back and look at challenges in clinical trials – invaluable studies without which there would be no advances in healthcare.

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Preventing professional patients is an overlooked issue in clinical trials.

Clinical trials in a nutshell

Clinical trials have been around since ancient times. In fact, the first clinical trial can be traced back to biblical times – in 500 B.C.! Since then, there have been many changes and updates to how these trials are carried out as well as standards that have to be followed to ensure they are ethical.

Clinical trials are conducted to develop drugs, devices, or procedures that can improve human health. These trials mainly help identify whether the drugs are safe, have any side effects, and can be used by the general population. 

While clinical trials used to be a very niche topic, its popularity skyrocketed due to the pandemic. Since the novel virus hit the world, virtually everyone has been asking the same question – when will there be a vaccine? Unfortunately, everyone skips over the challenges in clinical trials and they aren’t discussed as much as the vaccine itself. However, that’s exactly what we’ll look at today – some common challenges faced by organizations to carry out these complex, expensive trials.

4 common challenges in clinical trials

Clinical trials are not at all easy – they’re quite complex, lengthy, and are required to follow several rules and regulations to ensure compliance with different standards. Before starting a clinical trial and while running it, organizations face a number of challenges.

Slower patient recruitment than required

One of the biggest challenges is faced just before starting clinical trials, and it’s all about patient recruitment. Moreover, this is the stage that often determines whether the clinical trial will successfully commence or not as around 80% of these studies are either halted or even closed due to low patient recruitment. One of the reasons for this is the specific requirements of the trial. For instance, the trial requires patients to have a particular condition, but patients have other conditions as well which might lead to complications – finding the right patients proves to be quite a challenge indeed.  

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RightPatient addresses one of the overlooked clinical trial challenges – preventing professional patients.

One way many sponsors deal with this is by setting realistic expectations and assuming the fact that not all of their sites will attract the desired number of patients. Another way sponsors tackle the challenge is by outsourcing recruitment since there are several organizations available that specialize in doing so.

Compliance with several rules and regulations

Overcoming the patient recruitment challenge is just the beginning as there’s another herculean task. Ensuring compliance with the rules and regulations has to be ensured throughout the duration of the trial, as it cannot be completed successfully unless the trial conforms to the rules and regulations to a T.

Since trials are full of complex activities, involve human subjects, untested drugs, devices, and procedures, ensuring compliance becomes mandatory to ensure patient safety as well as maintaining ethics of the trials. Usually, institutional review boards (IRBs) have to approve the processes, and that can be time-consuming as there are many factors to consider, which often create a bottleneck.

Managing multiple sites

While clinical trials usually occur over multiple sites to involve diverse patients, more sites mean more vendors, procedures, diverse compliance requirements, and coordination efforts, leading to more complexities down the line. 

Creating a robust policy of how to deal with multiple sites and coordinate with one another is one of the only ways forward. Moreover, ensuring accurate patient records and properly managing patients is an absolute must to prevent mix-ups, inconsistencies, and ensure compliance. 

Preventing professional patients

Professional patients, or duplicate subjects, are an overlooked but significant issue that hampers clinical trials and threatens the integrity of the trials they participate in. Professional patients sign up for multiple trials either simultaneously or consecutively, which seriously affects the clinical trials. They can even lead to skewing overall data which might render promising drugs unusable since the data shows that the drugs are not effective enough.

Not only do professional patients harm themselves, but they cause billions of dollars in losses or delays in approvals from pharmaceutical regulatory agencies. As a result, preventing professional patients is a must – something which RightPatient can help with. 

RightPatient is a leading touchless biometric patient identification platform that ensures patients are accurately identified across the care continuum – several hospitals and health systems are already using it. Fortunately, it can prevent professional patients in clinical trials as well by validating that the patients’ identities and checking whether they are currently participating in other active trials or not. Not only can RightPatient help reduce significant losses, but it also helps protect the integrity of clinical trials – reducing errors and preventing professional patients from participating.

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Lack of Proper Patient ID Leads to “Professional Patients”

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Patient ID issues have always been prevalent in the U.S. healthcare system – we help solve these issues for healthcare providers. Today, however, we won’t talk about patient identification issues that exist in hospitals and healthcare systems – we will focus on the fact that the problem extends beyond the average provider. Unfortunately, many patients take advantage of the lack of a proper patient identity verification system and go repeatedly to their providers’ facilities and take advantage of healthcare services. Did you know that this happens within clinical trials as well? Let’s learn more.

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The importance of clinical trials

Clinical trials have a significant impact on conventional healthcare. They lead to breakthroughs that boost healthcare outcomes, reduce recovery times, and can even provide medicine to treat complex and previously untreatable diseases. When considering this topic, COVID-19 would likely pop up in most people’s minds. That’s what the whole world is fighting against currently, and the proposed vaccines developed by leading professionals are going through several clinical trials to determine the effectiveness of the vaccines and whether they have any undesirable side effects.

Thus, the importance of clinical trials is paramount for everyone involved. Likewise, the individuals who volunteer, known as clinical research patients, are essential as well. Let’s see what their motivations are to participate in these activities and what factors are at play that might put the entire trial at risk.

The lack of patient ID systems hurts clinical trials

Patients who participate in clinical trials are well compensated for volunteering. Many do it for altruistic reasons, and while compensation is based on the risks involved, the research is also vetted by an institutional review board. This is done to determine whether anybody enlisted solely for monetary benefits – many patients even enlist in multiple trials or sites. But why do they do so? How do they affect the integrity of the trials? How can an effective patient ID platform prevent this issue?

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Professional patients

There are some types of clinical trials where the financial benefits are quite lucrative for individuals who join more than one trial or participate at multiple sites simultaneously. Naturally, many do join these trials and expose themselves to either multiple doses of the same drug or single doses of multiple drugs undergoing testing. These types of patients cannot afford the money to pay for healthcare and thus sign up for multiple trials – they participate to gain access to both the treatment and the compensation. This is just one type of “professional patient” – let’s look at others.

The other type of professional patients falsify information regarding their medical condition – they don’t have the required condition but want to be a part of the trial. They can falsify information regarding the results and effects of the trial to show that they are participating – only to receive the compensation. As you can imagine, their participation in clinical trials may be extremely dangerous.

Another type of professional patient is individuals who actually have the required medical condition but they fake the results – they don’t want to be treated for the condition. These are quite common in trials involving research into treatment for addiction.

The consequences of professional patients

Getting exposed to multiple drugs that are still undergoing testing can lead to adverse effects for the patients. Other than patient safety, the reliability of the trials will be reduced due to integrity failure. Overall, the trials will experience significant losses due to the actions of a few. 

COVID-19 has already claimed over 965,000 lives while experts around the world are racing against time to come up with a cure so that we can finally go back to leading normal lives. If these professional patients participate in the clinical trials for a COVID-19 vaccine, the affected trials will be rendered useless due to the unreliable data these patients will provide. Even when a vaccine is developed it will lose credibility due to professional patients, delaying the most significant breakthrough we need. Is there any way to stop these harmful practices and ensure data integrity of clinical trials?

An accurate patient ID platform is the key

Professional patients are getting smarter about how to enter clinical trials now that information is available on social media. However, if there was an effective patient identification platform in place, it would be enough to prevent professional patients’ participation right from the start. That’s where we can help.

RightPatient is the leading touchless patient identification platform used by healthcare providers. They are using it to protect millions of patient records and prevent duplicates in their EHR systems by ensuring that patients are identified correctly across the care continuum.  

Since RightPatient has both the experience and expertise, it can easily prevent professional patients in clinical trials from fraudulent participation. This leads not only to enhanced safety of the participants within the trials but also makes the data immaculate and reliable – speeding up the trials and reducing losses along the way.

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How to Choose the Right Biometric Modality for Patient ID in Healthcare

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The following post on patient ID in healthcare was submitted by Michael Trader, Co-Founder and President of RightPatient®

We are excited to announce the release of a brand new white paper entitled: Choosing the Most Effective Biometric Solution for Patient Identification in Healthcare (Assessing the characteristics and capabilities of biometric options). The white paper assesses the capabilities and limitations of fingerprint, palm vein, and photo biometrics (iris and facial recognition) for patient ID in healthcare.

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Misinformation and confusion surrounding biometric patient ID hardware modalities are cleared up in our latest white paper.

The journey to select the most suitable biometric modality for patient identification in healthcare should include an assessment of hardware capabilities and limitations. This white paper was written and published as an educational resource for healthcare organizations to develop a deeper understanding of device characteristics and limitations. Due to persistent misinformation about the ability of select biometric modalities to perform accurate patient ID in healthcare and confusion on the realities of real world results post implementation we feel that this white paper stands as an authoritative guide that should be included in any and all comprehensive due diligence of biometrics.

Over 14 years of experience in real world implementations of fingerprint, palm vein, and photo biometrics has provided us with a wealth of knowledge and research on how these modalities operate when deployed and an authoritative resource to determine which devices can deliver on the promise that effective patient ID solutions offer:

  • Elimination of duplicate medical records and overlays
  • Prevention of medical ID theft and healthcare fraud
  • Increasing and sustaining patient data integrity
  • Increasing patient safety
  • Providing accurate patient ID at ANY point along the care continuum

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Did you know that select biometric modalities covered in the white paper do not have the ability to accomplish some of these goals? We encourage you to contact us and request your copy of this important and informative white paper to provide a more thorough background and understanding of biometric patient identification realities versus marketing fluff.

We are confident that you will find value in our research and analysis based on a decade and a half of experience in the biometric identification management industry and extensive experience with all of the modalities covered in the white paper. Please click here to request a copy of the research report. 

How to Choose the Right Biometric Modality for Patient ID in HealthcareMichael Trader is President and Co-Founder of RightPatient®. Michael is responsible for overseeing business development and marketing activities, government outreach, and for providing senior leadership on business and policy issues.