What Is a Decentralized Clinical Trial?

A decentralized clinical trial is defined as a trial in which trial-related activities occur at locations other than the traditional clinical trial site. This means patients can participate from other locations, including:

• Local health care facilities approved by the study team
• Your home
• The facility where you are living

In a traditional, on-site clinical trial, trial administrators conduct all data collection within a specific location. This ensures accuracy and preserves the integrity of the scientific research. However, decentralized clinical trials utilize software and digital solutions to collect data remotely, often providing the same quality and accuracy preservation as in-person trials without the need for physical presence. You may hear decentralized clinical trials called virtual clinical trials or direct-to-participant trials. All refer to the same type of experience.

Numerous types of decentralized studies exist, including those that offer a hybrid or fully decentralized model. Keep in mind that not all studies allow for this feature, as some research is highly specialized. Where possible, more studies than ever are moving to this process.

How Do Decentralized Clinical Trials Work?

Many think of clinical trials as being formal doctor’s appointments on a constant basis at a research facility. Decentralized trials eliminate or significantly reduce this need because they rely on digital connectivity. They must use digital tools like the following to collect data:

• Mobile apps you place on your phone to use every day
• Wearable devices that may track your physical activity, heart rate, or other specific data
• Video conferencing allows you to connect with, talk to, and even have a basic exam virtually

These tools may operate all the time or just for a specific period of time. What makes them incredibly valuable to research studies is that they collect data in real time and within your personal environment. That can be some of the most useful data available to the study, as it creates a more accurate view of what people experience in their daily lives.

Where Will You Have to Go for a Clinical Trial?

Some decentralized clinical trials will pair with your current healthcare provider. Your primary care physician will provide you with oversight following the direction of the study members. Other times, the trial may use a mobile healthcare provider to come to you or meet you within your community. This makes the study far more accessible to a larger group of people. As noted, some also use remote monitoring devices and apps to make the entire experience remote.

What to Expect When You Join a Decentralized Clinical Trial

Every trial is a bit different, but most follow a similar format. This typically includes:

• Applying for the study. You apply to the study and provide your information after reviewing the initial details about the research. If you believe you qualify, you can complete the application and submit it online.
• Meet with the investigators. The research team members or the decentralized clinical study investigator will connect with you. This is often done over the phone or in a video conference. Some studies may require you to visit the physical location at the start or at various times during the study.
• Receive devices. If trial administrators approve you and you are ready to be a part of the research, the study sends you any of the necessary devices to wear and teaches you how to use them properly. This may include wearable biometric devices that will monitor various aspects of your health, such as your blood pressure, blood oxygen levels, and heart rate.
• Receive necessary supplies. In situations where the trial requires you to use an investigational drug or medical devices, coordinators typically deliver them to your home or to your doctor’s office. Trial administrators will always provide you with very detailed information on how to use them.
• Apps track the process. Most decentralized studies utilize a web portal, software, or mobile app to track the required study information. This may be automatic, especially if you are using wearable devices. These devices transmit the data over Wi-Fi in a safe and protected manner. You’ll also use these apps to track side effects, experiences, or other data required by the study.

The study continues as expected. You continue to receive the hands-on care you need and the support you deserve. Like most clinical trials, these studies utilize safety steps while you receive treatment and monitoring. That means they will provide ways for you to contact the investigators or researchers if you have questions or concerns.

Are Decentralized Clinical Trials Safe for Participants?

Many of these trials require participants to submit information virtually to the participant. For those worried about the security of your private information or other risks involved, keep the following in mind:

• Rules apply. The Food and Drug Administration (FDA) provides specific guidelines for all organizations to follow. If they fail to do so, the study may not be valid. That includes providing protection for you, the participant.
• Safety monitoring. Trial administrators consistently monitor your safety throughout the study. You will also have access to steps to take and people to call if there is any risk to you.
• Informed consent. You will also learn as much as possible about the study beforehand, allowing you to make informed decisions about participation or risks.
• Privacy laws apply. You can still count on providers to meet all HIPAA rules and requirements to protect your privacy. If you are unsure, please ask questions about these steps.
• Transmission safety rules apply. The transferring of sensitive data is in a safe manner with the highest level of protection possible. Ask about these factors if you are concerned.

The goal of the study is to gather your information, not to put you at risk. Valid and trusted research centers want you to be safe in all ways throughout the process.

The Pros and Cons of Decentralized Clinical Trials

Should you participate in a decentralized clinical trial or seek out a full, more traditional format? There is no right or wrong answer that applies to everyone, but keep the following in mind.

What Are the Pros of a Virtual or Hybrid Clinical Trial?

• Reduced time commitments. You spend less time participating in the study in most situations. You typically do not have to travel to the site location, wait for appointments, or hope that the doctor’s office doesn’t have a long wait.
• Less expensive than in-person participation. These factors help to keep the cost of this type and level of care more in line with expectations. Even if the study pays or reimburses you for those costs, you may not want to participate if there are such costs.
• Technology advancements. Technology used in these studies gathers real-time data, and data that’s in your real-world environment. That can make the entire process more effective. It reduces the need for you to log information manually or to make sure the data is accurate.
• Protections exist. Some wearable devices enable the monitoring of adverse events, including symptoms or unwanted side effects. This allows the event participant to receive help sooner and may facilitate faster decision-making about moving forward with the study.

Most importantly, these studies open the door for more people to participate in them by eliminating or reducing the travel requirements. That makes them more likely to reach more potential participants.

What Are the Cons of Virtual or Hybrid Clinical Studies?

• Barriers to technology. Many of these devices are very new and may not be readily available in some areas. If you do not have regular access to a computer or smartphone, the study may be inaccessible to you.
• Privacy rights. Even with every strategy in place to do so, there is a need to collect health data in a virtual environment, meaning through the internet.
• Medication may be harder to obtain. Shipping medications or medical devices and teaching you how to use them can be challenging. Some medications, such as those sensitive to temperature changes, cannot be used in this manner.

How You Can Participate in Online or Virtual Trials and Research Studies

If you’re interested in participating in decentralized clinical studies, take a closer look at some of them available now. What you will find is a clear description of how they work and what you can expect. Start exploring opportunities that are not local to you.