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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 recordsWearable medical devicesPhone callsHome visitsLab 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 trackerSmart watch or ringGlucose monitorBlood 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.
Decentralized clinical trials
Centralized clinical trials
Location
Virtual or local clinic
Research facility or laboratory
Travel
Not required
Required
Time commitment
Possible virtual appointments
Travel and in-person appointments
Technology use
Requires an understanding of mobile apps, virtual appointments, and other health technologies
Does not require knowledge of health technologies
Drug studies
Requires the participant to store and take the correct medication dosage
The research staff manages the storage and administration of medications
There are benefits and downsides to both types of clinical trials. While decentralized trials are often more convenient for participants, they require participants to remember to upload their health data and participate in virtual visits. Researchers may not have as much control over the data collection as they would with centralized trials.
There are risks to any health study, including decentralized clinical studies. Possible risks include:
Side effects: There is a risk of side effects when you try a new health treatment or intervention. Researchers may not be aware of every effect from the treatment they’re trialing. Data security: Researchers store data from DCTs electronically. There is always a risk of a data breach with online information. Ask your research team what steps they take to protect your health data before joining a DCT.Access: People who are not comfortable with or do not have access to technology, like a home internet connection or smartphone, may not be able to participate in DCTs.
Participating in a decentralized clinical trial helps improve medical care for people in the future. There are several ways to join a DCT, including:
Ask your healthcare provider: Talk with your primary healthcare provider about current DCTs at your local healthcare facility and how you can get involved. Opt in to studies with wearable trackers: Many smart watches and rings collect data, with your permission, for outside health researchers. Fill out online surveys: Many DCTs require only online surveys or questionnaires. You can search for studies online and ask your healthcare provider for recommendations.
Decentralized clinical trials (DCTs) are health studies that collect data from human volunteers virtually rather than in a centralized location. During a DCT, healthcare providers will ask you to share specific health data through wearable medical devices, online portals, or virtual visits.
DCTs are usually more convenient for participants, allowing more people to take part in clinical research. To join a DCT, it’s often important to have a basic understanding of smartphones and mobile apps. Talk with your primary healthcare provider if you are interested in participating in a DCT.
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