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

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

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.