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Current Challenges in Clinical Research that Hamper Trials

June 1, 2021/7246 views / 0 Comments/in BLOG, Clinical Trials, Data Integrity, Patient Data, Patient Identification, Patient Safety, Professional Patients, Research /by Matt Gibson

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.

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.

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

May 7, 2021/6763 views / 0 Comments/in BLOG, Clinical Trials, Data Integrity, Patient Data, Patient Identification, Patient Outcomes, Professional Patients, Research /by Matt Gibson

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.

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.

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

May 6, 2021/6991 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).

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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.

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

May 5, 2021/7264 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.