Decentralized Clinical Trials: Will Location-Specific Studies Be a Relic of The Past?
Key takeaways:
A decentralized clinical trial (DCT) is a study that’s flexible in location. Rather than traveling to a specific clinical trial site, you may be able to participate from home or at a local healthcare facility.
Digital health tools are important for many DCTs. You may be asked to attend video calls with your clinical trial team or share health data through wearable sensors, smart watches, and more.
DCTs won’t completely replace traditional clinical trials. But we’ll likely see more of them in the future. Some studies already have a mix of traditional and decentralized elements.
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When you board an airplane, your safety is at the mercy of the airplane’s quality and the expertise of the flight crew. In today’s world, this should be reassuring. Aviation is a highly regulated profession with a seemingly endless list of safety checks.
The same is true for medications. Medications that are FDA approved for use in the U.S. have been vetted in their own series of safety checks. This happens in different phases of clinical trials. In these studies, health experts study a medication over a period of several years and evaluate how safe and effective it is. The FDA has strict approval criteria, so if a medication doesn’t meet their standards, it’ll never make it to pharmacy shelves.
That being said, participating in clinical trials isn’t always easy. There are strict enrollment qualifications, and most clinical trials take place at specific locations. If you aren’t able or willing to travel to where they’re happening, you likely won’t be able to take part.
Moving forward, there’s hope that this trend will shift. The FDA is thinking of ways to make clinical trials more physically accessible by “decentralizing” them. These studies could expand who can benefit from clinical research while also making study data more well rounded.
What is a decentralized clinical trial?
A decentralized clinical trial (DCT) is a study that offers flexibility in where clinical trial activities take place. This could include your home, a hospital or clinic in your town, or a nearby laboratory.
By comparison, a traditional (“centralized”) clinical trial is tied to one or more specific locations. This is usually a hospital, clinic, or doctor’s office that the study’s coordinators are associated with.
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For example, if you live in Texas and want to enroll in a Washington D.C.-based clinical trial, a DCT would allow you to sign up with little-to-no travel commitments. You could complete some or all of the study’s requirements — such as telemedicine appointments or blood draws — at home or a local Texas healthcare facility. If it was a traditional clinical trial, you would have to travel to Washington D.C. for the bulk of trial-related activities.
How do decentralized clinical trials work?
All clinical trials, including DCTs, collect data. This is one of their main purposes. Accurate and timely data allow healthcare providers to make decisions about how or when to recommend a specific medication (or medical device) to their patients.
If you’re not at a designated clinical trial site, data needs to be collected in a different way. Newer digital health tools are one answer DCTs may turn to. Depending on the trial, you may be asked to use one or more of these products:
A phone, tablet, or computer that can make video calls
A mobile app that you download onto a personal device
Wearable sensors, such as those that track and share your blood glucose readings
Smart watches or activity trackers, such as an Apple Watch or Fitbit
Digital health tools aren’t the only answer for DCTs. Your clinical trial team may also refer you to healthcare providers in your local area. If you need to go in person somewhere to receive treatment or monitoring, they may direct you to a nearby facility. Your local team will share any necessary findings with the researchers.
Good to know: Clinical trial logistics vary between studies. Before you enroll in a study, you should receive specific information about what your responsibilities are, what appointments you’ll have, and what equipment you’ll be using. This will help you decide if you want to participate or not (informed consent).
How do traditional, centralized clinical trials work?
Clinical trials, no matter where they happen, are complex. To help keep things simple, most clinical trials bring you on site so you don’t have to manage any logistics. This is a “centralized” or traditional clinical trial.
After the study coordinators tell you what the study will consist of, you can decide if you want to participate. They’ll then be in charge of giving you your treatment and monitoring your progress. By keeping everything in house, they reduce the risk of errors and mishaps. For instance, missed doses or improper monitoring in the outside world can impact the quality of the study’s results. It can also be risky for the person receiving the study medication.
For logistical and safety reasons, these types of treatments are better suited for a traditional clinical trial rather than a DCT:
Medications that are hard to administer, such as gene therapy medications
Medications that have a high risk of side effects or require intensive monitoring
Medications that aren’t easy to ship, transport, or take at home
Medications that are in early stages of development and don’t have much safety data yet
What impact do decentralized clinical trials have on participant diversity and inclusivity?
Traditional clinical trials aren’t feasible for everyone. They may be too far away from your home, requiring you to miss work or scramble to find child care. Travel costs can also be significant. Distrust or a fear of the medical system are common concerns, too.
These factors often lead to clinical trials that don’t represent the diversity of the real world.
Researchers are hoping DCTs can change this. By expanding who can participate in clinical trials, more people will have the opportunity to participate in research. Benefits of diversity in clinical trials and DCTs include:
Better treatments: Different people respond to medications in their own way. They may also be disproportionately affected by a health condition. By being able to study these differences in clinical trials, health experts can better figure out who would benefit most from a particular treatment.
Improved access to care: If you have a hard-to-treat health condition and current treatments aren’t doing enough, enrolling in an accessible clinical trial can offer new hope.
Drugs for rare diseases: Many drug companies want to make new medications for rare diseases. DCTs can introduce new clinical trial opportunities to people living with these conditions.
More trust in the research process: Past events have long-harmed the reputation of clinical research. But new laws and standards are in place, and working with local healthcare providers you trust can enhance the overall research experience for you and your peers.
Keep in mind that diversity has many forms. Race, ethnicity, and gender are important examples. But factors like your age, lifestyle, and where you live can also have meaningful effects on health and the inclusive nature of clinical trials.
What is the FDA doing to expand clinical trial access?
Alongside making approval decisions on new medications and medical devices, the FDA provides guidance on how to conduct clinical research. In recent years, this has included giving advice to pharmaceutical companies on how to conduct DCTs.
In 2020, the FDA released information about how companies can conduct DCTs in the era of COVID-19 and social distancing. In May 2023, it released even more guidance about how to conduct DCTs. The FDA is hoping that more location-flexible studies will help address certain public health needs.
How to join a clinical trial
DCTs won’t fully replace traditional clinical trials. But we’ll likely see more of them in the future. Many studies already have a mix of decentralized and centralized elements.
Regardless of where a clinical trial takes place, it’s important to know how to find and join one. Organizations like these can connect you to clinical trials you may be interested in:
Center for Information and Study on Clinical Research Participation
Advocacy groups for specific health conditions, such as breast cancer
Your healthcare provider is a handy resource, too. They should know about your medical history and treatment goals; they can point you to a clinical trial that you’re a good candidate for.
Keep in mind: Most clinical trials won’t be clearly labeled as decentralized or centralized. It’s important to read the study’s description to learn what your travel requirements may be.
The bottom line
Decentralized clinical trials (DCTs) are studies that aren’t connected to a specific location. Unlike traditional clinical trials that are tied to certain places, such as specific hospitals or clinics, DCTs allow people to participate in clinical research from home or at a local healthcare facility. DCTs often use digital health tools to collect data and monitor your progress remotely — reducing the need to travel to a traditional trial site.
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References
ClinicalTrials.gov. (n.d.). Learn about studies.
National Institute on Minority Health and Health Disparities. (2023). Diversity and inclusion in clinical trials.
U.S. Food and Drug Administration. (2023). CDER conversation: The evolving role of decentralized clinical trials and digital health technologies.
U.S. Food and Drug Administration. (2023). Conduct of clinical trials of medical products during the COVID-19 public health emergency: Guidance for industry, investigators, and institutional review boards.
U.S. Food and Drug Administration. (2023). Decentralized clinical trials for drugs, biological products, and devices guidance for industry, investigators, and other stakeholders.
U.S. Food and Drug Administration. (2023). FDA takes additional steps to advance decentralized clinical trials.
