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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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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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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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Prevent “Professional Patients” in Clinical Trials with an Effective Patient Identifier

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COVID-19 has changed reality as we know it since it was first detected. Everything and everyone has been affected, and now, it has reached every continent in the world. But we are hearing all around us that there is light at the end of this very long and dark tunnel. Fortunately, after months of struggle and research, several vaccines have been approved for emergency use. Researchers have worked tirelessly to come up with these vaccines, but there are several factors that could have jeopardized the vaccines – one of these is professional patients that participate in clinical trials. Let’s take a look at what professional patients actually are, how they hamper the integrity of clinical trials, and how an effective patient identifier can help prevent them.

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Clinical trials are more crucial than ever

Clinical trials occur on a regular basis and they are an integral part of healthcare. They lead to new drugs, treatment, and medical devices that reduce recovery times, improve healthcare outcomes, and treat complex or deadly diseases. However, as of now, everyone’s focus is on creating vaccines for COVID-19, which is why clinical trials have been in the spotlight for most of the year.

Clinical trials are quite lengthy and can be risky, but offer the reward of helping scientists arrive at key breakthroughs in healthcare. However, one of the trickiest parts is to recruit patients that fit the requirements of the trial. The volunteers are compensated handsomely and receive treatment for the conditions, but only after thorough background checks are conducted to identify any discrepancies.

That being said, factors such as the existence of “professional patients” can significantly hamper the efficacy and integrity of clinical trials. They can jeopardize years of research, cause millions in losses, and cause promising drugs to remain unapproved. Since there is no effective patient identifier used in clinical trials, professional patients mostly get away with hampering the trials. But what exactly are professional patients, and what are their motivations? 

Professional patients in a nutshell

Professional patients are those individuals that participate in clinical trials quite frequently, and many of them even participate in multiple trials at once. Yes, there are many types of professional patients. However, all of them create data quality issues and inconsistent results and are a hazard to sponsors, CROs (clinical research organizations), and drug companies.

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The first type of professional patients is simply those who have the required medical condition(s) and participate in clinical trials for financial gains. They usually cannot afford treatment for their medical conditions, and thus sign up at multiple facilities, either one at a time or simultaneously. Since they get exposed to multiple untested drugs and receive multiple doses of said drugs, they severely impact the data quality, their own health, and might cause promising drugs to not leave even the initial testing phases.

The other type of professional patients is those who have the required condition(s) but are not in it for the financial benefits. Instead, they falsify information down the line for something far more dangerous. These patients fake results not because they want the treatments; they want regular access to the drugs. These patients are common in treatments regarding addictions. 

The final type of professional patients is those who falsify information. They don’t have the medical condition(s) required by the trial but want to be a part of it. Not only do they falsify information during enrollment, but they can also give false information during the trial itself, which is extremely dangerous! It leads the researchers to make decisions based on incorrect information and can cause the trial to shut down. 

The lack of an effective patient identifier costs millions

Drug companies, sponsors, and CROs pour an enormous amount of time, money, and resources into clinical trials. Unfortunately, all of these are rendered useless by professional patients, and the unreliable data created by these individuals can cost millions. However, the best way to detect and prevent such cases in clinical trials is by using an effective, experienced, and well-reputed patient identifier.

An effective patient identifier ensures the integrity of clinical trials

RightPatient is the leading biometric patient identification platform trusted by several healthcare providers. Used by over 80 hospitals and thousands of clinics, RightPatient is the perfect solution to prevent professional patients in clinical trials.

Patients are assigned a single and unique biometric identity during registration, and they can be identified using mobile devices as well. If professional patients come in, the system can simply red flag them, if registered, and prevent them from participating in the trial, ensuring data integrity in clinical trials. 

Use RightPatient and avoid millions in losses, improve the efficacy of clinical trials, and optimize operations – contact us now to learn how we can help.

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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.