What To Know About Decentralized Clinical Trials As a Participant

Decentralized clinical trials (DCTs) are clinical studies that take place outside of a traditional clinical trial site. They are also known as direct-to-participant trials or virtual studies.

DCTs may offer several benefits, including convenience for participants. Evolving health technology, like wearable devices, makes DCTs possible.

Decentralized clinical trials are medical studies that you participate in virtually or at a clinic local to you. There is no central research site to visit.

Unlike traditional research studies, participants are not required to visit a centralized research facility. DCTs collect data using:

• Electronic medical records
• Wearable medical devices
• Phone calls
• Home visits
• Lab appointments

After you’ve found a decentralized clinical trial you’re interested in joining, you meet with one of the researchers to learn about the study and provide informed consent (your agreement to participate after the healthcare provider explains the risks, benefits, and alternatives to the trial).

If you decide to participate in the study, the researchers will likely provide any virtual tools you need. They may ask you to wear a device that tracks certain health data. Examples include pedometers, activity trackers, glucose monitors, and blood pressure monitors. You may also be given access to a mobile app to upload your information.

What You Can Expect

There are several ways to participate in a decentralized clinical trial. All clinical studies require a commitment to confidentiality. Before you agree to join the trial, ask the researchers how they will use and store your data and information.

After you provide your informed consent to join the study, you can expect the research team to provide instructions and any necessary tools. The team may ask you to wear a medical device such as:

• Pedometer or activity tracker
• Smart watch or ring
• Glucose monitor
• Blood pressure monitor 

These medical devices collect your health data for the study. To obtain your data, researchers may ask you to upload your data to a mobile app or an electronic medical record. If the study requires interviews, the team may schedule phone calls or virtual appointments with you. They may also ask you to complete online questionnaires or log other details of your experience. 

Participation in any clinical trial is voluntary. You or other participants may leave at any time. 

Decentralized clinical trials provide several benefits for study participants and health researchers. Conducting clinical trials virtually makes it easier for researchers to recruit participants and collect data to study. 

• Convenience: DCTs are usually more convenient for participants because they don’t have to visit a research facility. Many people prefer to receive their treatments or record their health information from home. This may allow more people to participate in clinical trials because it takes away barriers like time and travel. 
• Diversity: DCTs may improve the diversity in health studies because they allow more people to participate in scientific research. People with mobility issues can participate from home, and researchers can recruit people from populations who have been underrepresented in past health research. 
• Opportunity: People may participate from all areas of the country, rather than being limited to those who can access a central trial location. This can be helpful for studying rare diseases, in particular. 
• Cost: DCTs also reduce the cost of conducting a study because there is no central facility to manage. For participants, travel costs are significantly reduced.

Larger and more diverse enrollments in clinical trials mean the findings are more likely to apply to the general population.

Decentralized and centralized clinical trials are both health studies that use data from human volunteers.

In traditional, centralized trials, researchers collect data during in-person appointments at a research facility. In decentralized trials, researchers collect data virtually from the participants through wearable devices, mobile apps, electronic medical records, and virtual visits.