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4-Common-Challenges-in-Clinical-Trials-RightPatient

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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Lack of Proper Patient ID Leads to “Professional Patients”

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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EHRs: Why are physicians and patients dissatisfied with them?

Electronic health records (EHRs) are supposed to make things easier for doctors, improve health outcomes for patients, and create a better experience for everyone. However, most research indicates the opposite. There is a high level of EHR dissatisfaction among practitioners and the impact on patient experience has been underwhelming. So, what has gone wrong?

EHRs: Why are physicians and patients dissatisfied with them?When EHR system use became mandated, clinicians were expected to experience initial growing pains as they were forced to learn new skills. However, as comfort levels grew, their perceptions were expected to change over time, resulting in better communication and care. Unfortunately, doctors are still complaining about EHRs even after several years of widespread implementation and use. In fact, research shows that EHRs have become a major contributing factor to physician burnout.

The aforementioned Mayo Clinic Proceedings study also found that as many as 84.5% of physicians are using EHRs and the majority of them are not satisfied. Most physicians feel that EHRs are inefficient and require too much manual data entry where time is spent on clerical tasks rather than patient interactions.

Likewise, patients are also not satisfied with EHRs as they notice doctors spending more time looking at the computer screen during their visits. Research shows that gaze time (amount of time the doctor looks at the patient) is directly related to patient satisfaction.

Apart from data entry issues, a RAND study identified many other reasons for EHR dissatisfaction among physicians. For example, most physicians agreed that EHR interfaces were not intuitive, thus hampering their workflow instead of augmenting it. They also complain that EHRs are not implemented well enough to facilitate the proper exchange of information. Many physicians feel overloaded with irrelevant information.

Doctors also noticed that templates provided with EHR systems degraded the quality of their reports. Even more worrisome is that most physicians found that EHRs are not improving over time. 

Undoubtedly, these studies indicate the need for a system update and technology that frees doctors from having to spend time on routine clerical or data entry tasks. This technology would ideally enable clinicians to focus on their primary responsibility – carefully listening to, observing, and getting to know their patients so they can provide the highest level of care.

This is where RightPatient can help by providing an AI system that automatically identifies patients when they arrive and then engages with them to collect useful information that is pushed into the EHR system. This enables clinicians to understand much more about a patient’s condition while reducing their data entry burden. With RightPatient, doctors receive concise, relevant, and real-time information regarding their patients to save time, increase efficiency, and improve the patient experience.

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Making the most of patient wait times

The U.S. healthcare system has long suffered from the problem of excessive patient waiting times. In 2015, 32% of visits to the ED resulted in patient wait times of up to an hour. Obtaining an initial outpatient appointment with a physician can take a month or more. The fact is that waiting times can be unbearably long for patients and doctors are often helpless in solving the issue.

Making the most of patient wait times

Long waiting times can have a negative impact on a patient’s health by causing delays in consultations. Furthermore, wait times reduce patient satisfaction scores with healthcare service providers. Research has shown that patient satisfaction scores were affected across almost every aspect of care delivery when waiting times were long, with patients reporting lower levels of confidence in the care provider. Longer waiting times not only impact overall patient satisfaction, they also negatively affect the way that patients perceive the information, instruction, and care provided by their caregivers and physicians.

Clinics have adopted various methods to improve satisfaction while a patient is waiting for an appointment. These typically involve providing information regarding different disease conditions, tips on practicing a healthy lifestyle, etc.; essentially, they try their best to make waiting areas comfortable and informative. Additionally, some clinics use office staff to gather information from the patient. However, in many cases, the information provided by the clinic may not be relevant to the patient. Similarly, gathering information about the patient through staff is an expensive activity with limited benefits.

As we have seen, patient wait times can have a negative impact on both patients and their clinicians. However, what if there was a way to utilize these waiting times more productively? Can patients be engaged in a more meaningful way while they are waiting? This is precisely where RightPatient can help.

RightPatient can help to improve the patient experience and optimize wait times through its autonomous check-in process. When patients arrive for scheduled outpatient visits, RightPatient automatically recognizes them and engages through an AI-driven chat session. This enables patients to learn about their conditions as important clinical information is collected, which is automatically fed into the EHR. The clinical team can review this information prior to the consultation, saving time and increasing efficiency by eliminating the need for manual data entry into the EHR system. Physicians can then spend this time interacting directly with the patient to bolster satisfaction and clinical outcomes.

RightPatient enables doctors to spend more time focused on what they want to be doing – listening to patients, addressing their emotional and physical well-being, and spending less time worrying about data entry into health records. Satisfied and engaged patients also respond more favorably to more personal interactions with their caregivers, creating a win-win environment.