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

Life Sciences Review | Saturday, December 18, 2021
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RightPatient is a leading contactless biometric patient identification platform that guarantees patients are correctly recognized across the care continuum; RightPatient not only helps to eliminate major losses, but it also helps to maintain the integrity of clinical studies by decreasing mistakes and preventing professional patients from participating.


Fremont, CA: Clinical trials have existed since antiquity. However, the first clinical trial can be traced back to biblical times – 500 B.C.! Since then, there have been numerous changes and updates to how these trials are conducted and the standards that must be met to ensure they are ethical. Clinical trials are carried out to develop drugs, devices, or procedures that benefit human health. These trials primarily assist in determining whether the drugs are safe, have any side effects, and can be used by the general population.


Clinical trials were once a very niche topic, but their popularity skyrocketed due to the pandemic. Since the novel virus first appeared globally, almost everyone has been asking the same question: when will a vaccine be available? Unfortunately, in clinical trials, everyone skips over the challenges, and they aren't discussed as much as the vaccine itself.


Four typical clinical trial problems : Clinical trials are not simple — they are complex, time-consuming, and must adhere to a slew of laws and regulations to guarantee compliance with various standards. As a result, organizations encounter multiple problems before and throughout a clinical study.



  1. Patient recruitment is taking longer than expected.


One of the most challenging obstacles arises shortly before clinical trials, and it is all about patient recruiting. Furthermore, this is the step that typically determines 


whether or not the clinical trial will begin effectively since around 80% of these studies are postponed or closed due to a lack of patient recruitment. One of the reasons for this is the trial's unique requirements


. For example, the study requires participants to have a specific disease. Still, people also have other disorders that might lead to consequences - identifying the correct patients proves to be rather tricky.



  1. Observance of various norms and regulations


Overcoming the patient recruiting barrier is only the beginning; another titanic job awaits. Compliance with the rules and regulations must be ensured throughout the trial since the trial cannot be finished effectively unless it adheres to the rules and regulations of the letter.


Because trials contain human subjects, experimental medications, equipment, and procedures, ensuring compliance becomes critical to assuring patient safety while upholding trial ethics. Typically, institutional review boards (IRBs) must approve the processes, which may be time-consuming due to the numerous evaluation elements, which frequently creates a bottleneck.Managing Multiple Locations


While clinical trials are typically conducted across numerous locations to include a wide range of patients, additional sites entail more suppliers, processes, compliance requirements, and coordination efforts, which leads to more complications down the road.



  1. Keeping professional patients at bay


Professional patients, also known as duplicate subjects, are an underappreciated but severe issue that impedes clinical studies and jeopardizes the quality of the trials they engage in. Professional patients enroll in many studies, either concurrently or sequentially, hurting clinical trials. They can even bias statistics, rendering promising treatments worthless since the data suggests that the drugs are ineffective.


Professional patients not only inflict injury to themselves, but they also generate billions of dollars in losses or delays in approvals from pharmaceutical regulatory authorities. As a result, expert patient prevention is essential - something that RightPatient may assist with.


Fortunately, it may also prevent professional patients from enrolling in clinical studies by confirming the patients' identities and determining whether or not they are presently enrolled in other ongoing trials.


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