Decentralized clinical trials, or clinical trials where study participants do not need to physically meet at an investigator site for some or all of the study, have a growing place in medical research. Learn more about what decentralized clinical trials are and how they work.
What Are Decentralized Clinical Trials?
Decentralized clinical trials (DCTs), also known as virtual clinical trials or direct-to-participant trials, are defined by the U.S. Food and Drug Administration (FDA) as “a clinical trial where some or all of the trial-related activities occur at a location separate from the investigator’s location.”2 This usually means that DCTs are conducted virtually in part. DCT investigators may also work with your primary care physician (PCP) or a mobile healthcare provider in your area to make the study more accessible to you.
How Decentralized Clinical Trials Work for Participants
If you are a participant in a decentralized clinical trial, you may meet with investigators and healthcare providers online via video chatting or over the phone. You may also receive wearable biometric devices that measure your heart rate, blood pressure, and blood oxygen levels. If you’re in a trial studying an investigational drug or medical device, you may have it delivered to your home or you can pick it up from your PCP’s office.
Many DCTs also use online software or phone applications (apps) for you to track any information required by the study. You may have to input data from your biometric device or record the side effects of a medication you’re taking.
Keep in mind that DCTs are not always virtual or online, even if technology may be used to reduce the amount of travel required to a centralized trial site. You may still need to travel for study-related appointments or use local facilities such as labs for submitting specimens.
The Importance of Decentralized Clinical Trials
Decentralized clinical trials make participation in studies more accessible to more people. In traditional clinical trials, participants are largely tied to certain sites that run the study. The frequency of travel required to a particular study site for the length of the trial might not be feasible for many potential participants.
Especially during the start of the COVID-19 pandemic, many clinical trials were stopped or put on hold because they required in-person visits and testing. These holds were put in place to protect more vulnerable populations from exposure to the virus. However, this also delayed the research needed to approve new therapies, medical devices, or procedures.
To help maintain social distancing, the medical field began using virtual visits more regularly as a way for clinicians and their patients to continue to meet. Clinical trial investigators likewise saw the merit of using virtual studies, or decentralized clinical trials, to continue to study new treatment methods and devices even during the pandemic. DCTs allow investigators to continue to advance the scientific and medical fields with the help of volunteers participating from their own homes, or in sites closer to their homes.
Benefits of Decentralized Clinical Trials
With DCTs becoming popular in response to the COVID-19 pandemic, investigators and researchers are learning more about their impact. Some advantages of DCTs include reducing the time commitment required for participants, boosting participation with easier access to studies, and using technology to keep investigators and participants connected throughout the trial.
Reduced Time Commitment for Study Participants
Traditional clinical trials often require a significant time commitment for the participants to travel to the trial site, potentially stay at a hospital, and/or have tests done. In-person visits can increase the costs of participating in a trial for many who have to pay for transportation, meals, hotel stays, and childcare. Even if studies offer payment or reimbursement to participants, certain costs to participants may not be fully offset. As a result, investigators sometimes find it difficult to recruit participants and keep them until the end of a study.
DCTs offer a way for more people to participate in trials because many are conducted from the comfort of their homes. Any medications and wearable tracking devices used in a study may be sent to the participant’s home. In virtual DCTs, the need to travel for in-person visits and lab tests is reduced or eliminated, which in turn reduces many of the barriers to participation.
People who may not have been able to join a trial before are now able to, meaning investigators can recruit participants more quickly or can recruit a more diverse group of participants. Increased diversity in trials helps investigators see how a new treatment or device works in people of different ages, races, or ethnic backgrounds.
If you’re living with a rare condition or disease, DCTs can also be a way to bring together others who are also affected for a clinical trial. It’s unlikely that everyone with a rare condition lives close enough to each other that a clinical trial can be conducted at a single center. Instead, virtual visits with investigators and healthcare providers can make a study possible.
Technology Benefits
Another advantage of decentralized clinical trials is that some of the data may be collected through real-time monitoring using wearable devices. This means that investigators can collect data more often than they could in traditional clinical trials.
In addition, apps can send notification reminders to participants on their phones for completing questionnaires, tasks, or taking medication. This helps them stay on track for timely tasks, making it easier for the investigators to collect accurate data. Investigators can also track participants’ activity and reach out to them directly to help them stay compliant in a study. When indicated, subjects can even take assigned medications while on a video call with the investigators, documenting their adherence with the protocol.
If a participant begins experiencing an adverse event (unwanted side effects) from a treatment, wearable tracking devices may be able to detect these events. Often, adverse events aren’t found or reported until a study participant attends an in-person appointment with the study investigators, which may be days or weeks after they begin. Real-time monitoring can alert investigators to these events when they begin, letting the participant make an appointment for support or care. An investigator can then follow up with them after the event over the phone or by email to document the event.
Having direct access to the investigators through apps or other software gives more opportunities for participants to engage with them. This can be empowering and helps many participants feel like they’re playing a more active role in their health.
Cost Savings
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Traditionally, the clinical trial process is long and expensive, taking between 6 to 15 years and costing around $2.6 billion per drug. This means that it takes time before a drug treatment is available to people who need it — and when it finally becomes available, the retail cost may be too much for some.
DCTs can significantly cut costs by reducing the number of sites and staff needed for a study and requiring fewer institutional review boards (IRBs). Most DCTs collect data consistently, limiting the number of in-person visits needed for the same amount of data.
If study data is collected more efficiently, a clinical trial can potentially be completed less expensively and more quickly. Theoretically, this efficiency can result in approved treatments reaching the public sooner and at lower retail cost.
Drawbacks of Decentralized Clinical Trials
While there are many benefits to DCTs over traditional clinical trial setups, there are still some challenges that investigators face. The spike in DCTs is fairly recent in response to the COVID-19 pandemic beginning in early 2020. With this, investigators and researchers are still learning and adapting to new technology and study setups.
Technology Barriers
Wearable devices used to measure vitals and monitor participants throughout a study are still relatively new. Some devices are still in development and need clinical research before they can be used in studies. They may also rely on an internet connection, batteries, or other factors that can be difficult for participants to control. This can limit study participation in rural areas or for those who don’t have regular access to these resources.
DCTs also rely heavily on technology, including computers and cell phones. While some populations may intuitively know how to operate these devices, other populations may have more difficulties. This can discourage those populations from participating, making it more difficult for investigators to recruit participants from, for example, older age groups. Virtual visits can also feel more impersonal than in-person visits, which may also prevent some people from joining a study.
Complexities in Protecting Participant Privacy and Rights
Another factor to consider is the protection of a participant’s privacy and the health information collected during the clinical trial. If a wearable device is connected to the internet, it has to have the proper security measures to prevent unauthorized access. DCTs may also use different electronic health record systems to keep track of the participants. In traditional clinical trial setups, information can be stored in one central location. However, DCTs can have multiple healthcare providers contributing information from several different locations, complicating the data collection and protection process.
The boards that monitor safety and the rights of participants have also had to adapt to new clinical trial setups. These boards (IRBs) are required by the FDA for any clinical trial that receives federal funding. These boards consist of doctors, scientists, and community members who monitor the ethics, privacy, and safety of studies. As DCTs become more common, IRBs will have to become familiar with new technologies and monitor multiple providers across several locations.
Access to Medication
While it may seem convenient, there are also risks of shipping medication or medical devices to participants’ homes. There may be an issue keeping treatments within acceptable storing conditions, such as at a certain temperature, during shipment. The participant then has to correctly store the medication at home to make sure it’s as effective as possible. If there are any issues with these factors, that could skew the results of the study. Some states may also have laws in place that make it more difficult to ship medication or devices.
How to Join a Decentralized Clinical Trial
DCTs offer many people a way to join a clinical trial without the significant time commitment required by traditional studies. If you’re interested in finding a DCT, talk to your doctor or begin a search. To join a clinical trial, you’ll have to meet the inclusion and exclusion criteria set up by the investigators. These are requirements that you must meet to join a study. If you qualify for a DCT, the investigators will then get your informed consent and begin the trial process.
