Decentralized clinical trials have quickly become one of the hottest topics in clinical research. But many research sites still have concerns about a decentralized clinical trial model, worrying that sponsors will use technology to bypass them and go straight to patients.
 
The good news is that decentralized clinical trials will not eliminate the site. In fact, a decentralized trial model can help sites gather more diverse and inclusive data and provide better one-on-one care to patients. If research sites stay open to change and invest in the right remote technology, decentralized digital trials will benefit research sites just as much as sponsors and patients.

Benefits of Decentralized Trials for Research Sites

The Florence Healthcare State of the Industry Survey suggests that 83% of clinical trial sites and 80% of sponsors have invested in remote technology, and 80% of sites think this trend will continue beyond 2021. The ACRP and FDA have also discussed the importance of decentralized trials, so research sites need to embrace the possibility of using remote technology.  
 
Fortunately, decentralized trials have multiple benefits for research sites, including the collection of real-world data, meaningful visits between clinical research staff and participants, and access to a wider range of partipants.
 
In a decentralized trial, investigators don’t just collect data when participants are at the research site. Participants can leverage solutions such as ePro to send data to the investigators automatically or self-report their experiences using apps and online software. This allows clinical research staff to gather information about participants’ day-to-day experiences outside of the controlled environment of the research center.
 
Letting participants submit data remotely comes with another important benefit. If clinical research staff don’t have to spend a participant’s entire visit gathering basic data, they have more time to talk with the participant and provide personalized care.
 
The National Institutes of Health report that patients with an illness often participate in clinical trials to receive extra attention from the clinical trial staff. If patients have access to remote technology that records and reports their data before they arrive at the research site, they can spend their in-person visits receiving medical treatments and advice.
 
The third and arguably most important benefit of decentralized trials is their accessibility. In a traditional, centralized trial, participants need to visit the research site frequently. People who live in rural areas, don’t drive, or work restrictive hours could therefore be shut out of the clinical trial. With decentralized trials, these people can join the study and share their data remotely.

How Sites Can Use Decentralized Trials to Increase Diversity

Making trials more accessible is critical, because the current demographics of clinical trials don’t accurately represent the U.S. population. According to the ACRP, 13.4% of the U.S. population is Black, while only 5% of trial participants are. Latinx people are even more underrepresented, making up 18.1% of the population and only 1% of trial participants.
 
Offering decentralized trials won’t automatically increase the diversity of research participants, but it could help. Kim Doggett, Head of Site Engagement for UCB, notes that decentralized trials let sponsors and researchers work with local physicians and pharmacies to reach underrepresented populations. People may be more likely to participate in a trial if they can visit a local doctor who they trust and rely on public transportation to reach their appointments.
 
Decentralized trials can also help participants of lower socioeconomic status. The ACRP’s research suggests that people with an annual household income below $50,000 were 27% less likely to participate in clinical trials than people who made more than $50,000 a year. With remote technology and the ability to visit local sites, lower-income patients can participate in trials even if they can’t miss work or don’t have a car.

How Research Sites Can Prepare for Decentralized Trials

When preparing for decentralized trials, research sites will need to focus on how they obtain and share data. Data could now come from wearable technology, telehealth appointments, and local physicians as well as from participants’ appointments at the site. That means research sites will need to invest in software that lets data be shared across multiple locations.
 
But how do you find technology that’s functional, secure, and aligned with FDA and GCP requirements? As useful as cloud-based drives and emails are, they often don’t comply with clinical trial regulations. To make decentralized trials viable, research sites need to invest in software designed specifically for the industry.
 
Sites also need to make sure their remote technology is flexible and intuitive. Most clinical research assistants and coordinators don’t have time to study a complex software system. They deserve excellent customer support and training as well as technology that’s easy to use.
 
Finally, research sites should look for technology that can easily integrate with other programs. Software that can integrate with other systems will help you keep your regulatory, consent, and source data online so you don’t have to deal with half your records being electronic and half being in paper files that are difficult to access.

Research Sites in a Decentralized World

Research sites will always play a critical role in clinical trials, because clinical trial participants value their connections with investigators and clinical research staff. But embracing technology can help more participants get involved in trials and help researchers obtain valuable data from neighborhoods, homes, and pharmacies as well as the medical center. With secure, compliant software, every research site can carry out effective decentralized trials in the future.
 

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Marc Leighton is Florence Healthcare’s VP of Product, joining the team with a rich background in global healthcare and delivering innovative solutions to customers. Before coming to Florence, Marc served as a Strategy Partner for Cleveland Clinic, acted as Global Product Director for GE Healthcare, and held various leadership positions in a Revenue Cycle consulting and operations capacity.