Top Challenges of Decentralized Trials and How To Overcome Them

Table of Content

1. Decentralized Trials Challenges

2. Decentralized Trials Solutions

3. Decentralized Trials Have Their Challenges, But They Open New Doors

Clinical trials have always been an important part of medical product development. Typically, they were performed in person.

Since the COVID-19 pandemic, however, a new approach to clinical trials has been developed to keep up with the rapidly changing healthcare practices that aim to keep patients and healthcare providers healthy. Many organizations have turned to decentralized clinical trial models, which allow them to conduct clinical trials remotely.

The virtual approach to collecting data helps in many ways. Perks like working with a large patient population or increasing the ease of participation for people who want to be part of a trial cannot be overlooked.

However, the remote collection of data is not without risks or concerns. There are challenges, including:

• Compliance issues
• Data tracking
• Patient engagement
• Patient centricity
• Integration with new technologies
• Data quality and integrity
• Collaboration and support needs

The good news is that it's possible to overcome these issues and create a decentralized clinical trial that achieves everything it's supposed to while maintaining compliance, engagement, and integrity.

Decentralized Trials Challenges

Decentralized clinical trials (DCTs) are clinical trials that have some or all of their activities performed outside traditional clinical trial sites. Alternative sites might include:

• A nearby laboratory
• A local healthcare facility near a participant
• The participant's home address

In this kind of trial, the goals are the same as with any other kind of clinical trial, but there are differences in how those goals are achieved. It also presents unique challenges that require careful consideration and strategic thinking.

Compliance Issues

Among the primary challenges unique to decentralized clinical trials are compliance issues. While it's evident that remote data collection can improve how well patients adhere to a trial, it is more difficult to authenticate the data and where it's coming from. For example, if data is collected through wearable devices, they can be easily transferred to another person, which can be problematic.

Going remote can also complicate other aspects of compliance. In particular, privacy becomes a considerable issue with DCTs. For instance, patients may upload data over unsecured Wi-Fi. Or, there could be multiple clinics involved, exposing the collected data or samples to transportation or storage compliance issues.

Compliance issues could lead to fines, which researchers, clinicians, and organizations always want to avoid.

Data Tracking

Organizations can also run into data tracking issues during a decentralized clinical trial. Wearable devices record and accumulate data 24 hours a day, seven days a week. Mobile phones can also track around the clock. For organizations, this influx of data means they have to be prepared to store mass amounts quickly and in an organized manner.

On top of tracking and storing data, organizations must carefully consider where the data is coming from and the formats in which it's delivered so it can be used across multiple clinical sites or accessed when needed.

Patient Engagement

When patients don't have to visit a clinic regularly for follow-up care or support during a trial, it's even more important that they're kept engaged throughout the process.

It's no surprise that recruiting and keeping trial participants on board is difficult because patients have different preferences for interacting with their healthcare providers and clinicians. Some may prefer to have a face-to-face meeting to discuss their concerns, while others might like to call in through telehealth.

Decentralized trials may also struggle with retention, but they can reach those who otherwise may not have had the opportunity to participate in person. So, there is a trade-off, and there may be times when decentralized trials are better when they take a hybrid approach to participant interactions.

Patient Centricity

Patient centricity refers to the approach where the needs and preferences of participants are prioritized and integrated into the trial process. It helps encourage trial participants to be more proactive. However, it can be difficult to make the process patient-centric within a decentralized clinical trial.

Remember, DCTs take place remotely and involve new technology that patients may not be familiar with. This may make it difficult to make the trial patient-centric due to the geographical diversity of the patient population, technological barriers, and logistical issues.

Integration With New Technologies

Decentralized clinical trials often incorporate additional technologies, such as digital health technologies (DHTs), that send data from the individuals to the researchers directly. Common types of DHTs include:

• Wearable monitors, such as pedometers or exercise watches
• Implantable monitors, such as glucose monitors
• Ingestible monitors, such as capsule monitors

Working with multiple technologies and systems can be frustrating for trial participants. In addition, decentralized trials implementation can be challenging for researchers because the data collected during a trial must be stored securely and transported safely.

Data Quality and Integrity

Digital technology is amazing because it enables easy data transmission over Wi-Fi and allows data to be stored in the cloud. Data can also be transferred using discs or drives, stored on memory sticks, or even mailed to others on SD cards.

In decentralized clinical trials, maintaining data integrity is of the utmost importance. Data has to travel from Point A to Point B without getting lost or tampered with. Data must also be authenticated to ensure it contains accurate patient information. More importantly, data has to be transferred following the laws and regulations regarding patient privacy.

Collaboration and Support Needs

Collaborating can become a significant challenge for those involved in decentralized trials. Collaborators may be spread over several sister clinics or not in the same state, region, or country. For participants, being so far away from people who can quickly help them with the technologies used to track their data can create complications.

Decentralized Trials Solutions

Several solutions can help relieve stress from the most common challenges in decentralized clinical trials. Changing your approach in working with participants, handling data, or designing the format of the trial can make a big difference in the outcome.

What To Do When Working With Participants

Patient engagement and compliance improve when patients understand how to use the technology involved in a trial. Conducting training sessions or ensuring patients get easy access to support can ease their minds and keep them committed to the trial.

To ensure patient centricity, researchers must strive to put the participants' needs first. Rather than only getting feedback as the trial progresses, the better option is to first listen to the patients and make notes of their wants, needs, and concerns.

How To Handle Decentralized Clinical Trial Data

In handling data collected from remote monitoring devices, individuals running the trial should ensure the stored data stays within secure networks. The U.S. Food and Drug Administration has created Level 1 guidance on how to collect data from remote clinical trials, which researchers and organizers can use to ensure the data is handled, stored, and transferred correctly.

Some options to collect and manage data for DCTs may include:

• Electronic patient-reported-outcome (ePRO) tools
• Apps
• Wearable devices
• Ingestible devices
• Implantable devices

Using these devices appropriately and maintaining good-quality data may require collaboration with information technology (IT) departments.

How To Create a Collaborative Environment Remotely

There is a strong need for collaboration between professionals and participants in decentralized clinical trials. Most DCTs will be hybrid, which means you will occasionally meet with other parties involved in the trial. However, since meetings may be rare, it is easy to end up feeling isolated, which hinders the collaborative process.

For participants, having regular check-ins in person or through telehealth can help, even if those check-ins are spread further apart than in a typical trial scenario. Similarly, using video calls or chats versus phone calls can make participants feel more like they're a part of a real process rather than just a voice with necessary data on the other end of the line.

For professionals, creating an environment where key teams can easily work together should be a priority. Starting from proof-of-concept, those involved in the virtual or hybrid space should become familiar with one another. For example, organizations can benefit from having the internal regulatory staff get to know health technology teams, as they may end up working together to solve problems and create a better virtual environment for participants.

Decentralized Trials Have Their Challenges, But They Open New Doors

While DCTs present challenges that make them more difficult to set up, structure, manage, and analyze, they also create scenarios in which more participants can get involved and more diverse datasets can be collected. Thanks to decentralization, trials can expand their reach to involve more patient demographic groups, and data can be collected consistently from the very first day.

With the right approach, hybrid DCTs have plenty of benefits for both clinicians and participants, setting them up for a successful collaboration.

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