Decentralized trials are clinical trials that are either completely remote or hybrid. They have grown in popularity since they were introduced during the COVID-19 pandemic. The decentralized method has many benefits, which include removing the need for on-site visits and collecting around-the-clock data with the implementation of Wi-Fi or cellular medical technology.

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With that in mind, it's also important to understand that decentralized trials have their own risks and challenges. Research sites, sponsors, and clinical or contract research organizations (CROs) need to consider them before setting up their own decentralized trials.

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Here are the common challenges and risks that research professionals may come across during a decentralized trial.

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Accessibility and Flexibility

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There is greater accessibility and flexibility in decentralized trials. In fact, without the need for on-site visits, trials can be accessible to those with only an internet connection or phone line. Additionally, those with illnesses or other health concerns won't have to drive far for specific trials that could help them recover. This reduces the travel burden on the patient and gives them more opportunities to be involved in trials that they may otherwise not have access to.

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However, decentralized trials can hinder access in certain circumstances. For instance, some participants may need to familiarize themselves with the technology involved in a trial, making it difficult for them to participate. And some don't have access to the internet, especially those who live in remote or underserved areas. As of 2022, one in five U.S. households was not connected to the Internet, showing just how much of the population could be limited by that one factor alone. On top of that, it's also necessary for research professionals to understand that internet access may vary by region, essentially skewing results or cutting out certain demographics completely.

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What's the Solution?

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The best way to ensure that most people can participate in a decentralized trial is to incorporate flexibility. Creating a hybrid trial—one where participants can come to a trial site and engage remotely—may create the most opportunity for people to participate.

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Additionally, offering support with internet access, such as by suggesting low-cost or no-cost options or providing access via cellular devices, could help encourage those who face accessibility barriers to join the trial.

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Siteless Trial Concerns

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It's no secret that clinical trials are costly, and cutting costs is important for extending the life of the trial period. However, some research sites are worried that siteless trials will become the way of the future, effectively eliminating the need for research facilities.

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Cutting research sites reduces costs and allows patients to receive direct service, but some challenges could arise. For example, participants who need medical care or guidance from medical staff members may not have a local site they can visit to get the support they need. It is also harder to ensure that all participants correctly use the medical technology and medications required in a trial.

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What's the Solution?

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The simple solution to this problem is to have hybrid decentralized trials rather than completely remote ones. Decentralized trials aren't always siteless—many require in-person visits at least a few times throughout the project. With hybrid trials, it's simpler to verify that patients understand how to take their medications or to help them set up their wearable medical devices, helping boost the likelihood of a valid trial.

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Software and Technology

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Software and technology issues are some of the most significant concerns for those looking into developing decentralized trials. Decentralized trials require technology that quickly sends data from wearable, implantable, or ingestible medical devices to the research sites. That same data must also be safely transferred to the CROs and trial sponsors.

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Since the data includes sensitive patient information, all data transfers must be secure. Exposing patient data during a decentralized trial could lead to heavy fines and penalties for violating regulations such as the following:

• Health Information Portability and Accountability Act of 1996 (HIPAA)
• U.S. Food and Drug Administration CFR Part 11
• General Data Protection Regulation (GDPR)

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In addition to data concerns, the learning curve for participants must also be considered. Participants who have access to Wi-Fi and computers may already know how to use wearable technology or upload data correctly. However, some participants may need access to these items or may need more experience to use them.

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What's the Solution?

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Choosing the appropriate technology to keep data secure while ensuring smooth and easy data transfer is quite the task. However, working with medical software vendors and staying informed about national and international clinical research guidelines helps prevent significant errors. The Studypages platform is designed to address research data security needs. Our secure and compliant technology enables teams to communicate seamlessly and collect data efficiently from participants, thereby enhancing the overall research process. By ensuring both data security and operational efficiency, Studypages supports clinical trials in meeting rigorous standards and achieving their research goals.

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It can also help improve the participants' experience if clinicians provide user-friendly software and devices. In addition, software vendors and clinicians should work together to learn how to use the devices properly and then effectively share that knowledge with the participants.

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Hybrid trials may be a good choice in areas where there is a data literacy gap to consider. In a hybrid setup, participants would have access to professional support that would be lacking in a remote environment.

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Protocol Deviations

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When it comes to staying in line with the requirements of a trial, it's much easier to do so when all participants have to check in at a facility. Participants are more likely to stick to the rules if they have to come and see the clinicians, which helps ensure that the right data is collected.

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When participants are tasked to send in their own data, there is a risk of error. For example, they may:

• Record their data incorrectly
• Forget to turn in data
• Let someone else wear a piece of medical equipment and record data that isn't their own

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These risks and other issues are a serious threat to the validity of a clinical trial.

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What's the Solution?

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Decentralized clinical trials can still be successful even when remote. For fully remote trials, training patients to properly use their devices and upload data correctly is imperative. A clinical trial could also have an automatic reporting requirement, which would allow data to stream to the research site from wearable, implantable, or ingestible medical devices with no patient input required.

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As for addressing the issue of human error, a good strategy is to implement a localized trial rather than a completely remote one. With this hybrid approach, patients will need to check in with their local healthcare providers when they have to turn in data. They may go to local pharmacies or doctors' offices, for example, and medical providers there would collect the data for the research team.

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Data Overflow

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With the potential to collect data around the clock, it's not surprising that data overflows are common in decentralized trials. Decentralization allows clinical trial researchers to gain deeper insight into participants' health throughout the day or in a number of environments, but the sheer amount of data can be overwhelming.

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If data is not managed correctly, decentralized trials can end up taking much longer to finish than standard trials. Researchers will need to sort through all kinds of data, which is a time-consuming task.

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What's the Solution?

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The right software makes a difference. Using software that can collect and organize data into categories can help minimize the extra time clinicians have to spend on sorting data. Additionally, electronic data capture (EDC) systems may integrate with electronic investigator site files (eISFs), making the transfer of data between them possible without glitches or risk of data loss.

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Organizations Can Overcome Decentralized Trials Challenges

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There are significant challenges in using a decentralized model for clinical trials, but the perks often outweigh them so long as the appropriate support systems are in place. With benefits such as increased flexibility for patients, more thorough data, and the potential to include more participants from distant locations, decentralization makes sense. However, clinicians must be prepared to deal with the challenges, such as having an overflow of data or a lack of local support for participants to make their trials as effective as possible.

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At Studypages, we believe the advances in clinical research are revolutionary, and the benefits of decentralization cannot be ignored. To learn more about decentralization and how we're helping boost clinical trials with automated and intelligent workflows, visit us online today.

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