Decentralized trials will have a major impact on study sites and the clinical trial process. Some organizations refer to decentralized trials as “site-less” trials, but we disagree.
As a clinical trial technology vendor we think that, rather than taking power away from sites, trials that harness technology will let sites spend less time on paperwork and more time getting to know their diverse patient populations.
When we talk about decentralized clinical trials, we mean using technology to give patients easier access to research sites in their local area. They can check in with their physician from home, visit a local pharmacy or doctor’s office, and even record data about their symptoms using a secure app.
This all sounds great for patients, but how does it work for research sites?
Here are five impacts clinical research sites can expect to see as decentralized trials become more common.
1. Allotting More Time for Who Matters: The Patient
A traditional clinical trial model forces providers, principal investigators, and coordinators to spend patient visits collecting data.
Incorporating decentralized trial technology into the study lets researchers collect most of this data via smart devices and other ePRO tools.
When physicians have the data in advance, they can spend patient visits interacting with the participant and listening to their thoughts, concerns, and experiences.
2. Connecting More Patients with Studies
Traditional clinical trial models often accidentally exclude diverse patient populations.
According to the ACRP, African American, Latin American, and low-income patients can end up underrepresented in clinical trials because trials aren’t offered at their primary health care providers (HCP), the study locations lie too far from their homes, or scheduled visits interfere with their jobs. (1)
When implemented correctly, decentralized trial designs reduce or eliminate many of these barriers to participating in a study.
Patients can check in using apps or at-home devices and can make appointments at local pharmacies and testing sites instead of traveling long distances to research centers.
Decentralized trials can also increase patients’ trust in clinical research. For example, UCB, a well-known research sponsor, has discovered that when patients work with their local HCP or talk with researchers at pharmacies and community centers, they may be more likely to believe that researchers genuinely care about their concerns and their well-being. (2)
3. Hiring New Roles to Support Digital Research
With the rise of new technologies at clinical trial sites and patient-facing apps, clinical research sites will need to hire or train people for jobs that previously didn’t exist.
For example, digital research navigators, professionals who help sites and patients understand new technology, have started springing up at medical centers as well as at CROs and sponsor organizations.
Although many coordinators and physicians appreciate navigators guiding them through using new software, navigators’ most important job is advocating for patients.
Mobile apps and WiFi are widespread, but many patients still can’t access or don’t understand how to use cloud-based software. Navigators can help patients become comfortable with apps or telehealth calls and can also create individual accommodation plans for patients without cell phones, computers, or Internet access.
The roles of clinical research coordinators or clinical research assistants may also change as digital tools become more widespread. For example, clinical research assistants may find themselves uploading documents to a secure online system rather than filling out paper forms. This will help CRAs save time so they can focus on getting to know patients instead of digging through binders.
4. Allowing Opportunity for More Remote Work
While remote work became the standard during COVID, Florence’s State of the Industry 2021 survey shows that many research sites expect this trend to continue. 83% of sponsors and 80% of sites believe most clinical trial monitoring will be remote by 2023.
Sites love being able to hire the best clinical research professionals in the field without worrying about their geographic location, and working from home saves employees from long commutes and unnecessary stress.
Remote work is also great for sponsors and CROs. With the rise of remote monitoring, monitors don’t have to hop on a plane and spend days or weeks away from their family just to leaf through a binder filled with paper documents.
Sponsors and CROs can quickly check on essential documents through software like Florence SiteLink™, and sites can easily upload their documents and give monitors access to them.
When monitors do have to travel, such as for site initiation visits, they can spend their time getting to know the clinical research team instead of staring at papers.
5. Increasing Access to Data and Real-Time Observations
Decentralized trials give site staff and sponsors the ability to see beyond a single patient visit.
In the traditional clinical trial model, the patient comes into a controlled environment for a short period, so physicians and researchers only get a quick snapshot of how that patient is doing. If physicians need more data, the patient must make more visits, which can be physically and financially draining.
With wearables and other forms of ePro technology, researchers can collect data from the patient in real time and in a wide range of environments. The patient can continue working, caring for their family, and living their life while their doctors gather important data about their treatment.
But clinical research software doesn’t just give site researchers greater insight into how their patients are doing. It also gives sponsors greater insight into how individual research sites are doing.
If you’re conducting a multi-site study, you can quickly log onto your remote monitoring hub or Electronic Trial Master File and see which sites have submitted their regulatory documents or data and which have not.
In general, clinical trials benefit from having more data. With a large data set, researchers can evaluate not only how well treatments work but how well they work among diverse populations and in diverse environments. However, the amount of data collected can also become overwhelming.
Sites need the right software and an experienced clinical research navigator to ensure that relevant data is shared with sponsors and irrelevant data is not. Even with those caveats, however, we believe most researchers will benefit from having abundant, accurate patient data.
Looking Toward the Future with Decentralized Trials
Decentralized clinical trials bring together many of the most important trends in clinical research: patient-centeredness, diversity and inclusion, evolving roles for researchers, remote work, and increased access to data. But to make the most of all these trends, sponsors, sites, and technology vendors need to work together to ensure every change they make serves not only the industry as a whole but, most importantly, their patients.
Florence helps study sites and sponsors navigate this new approach to research. Thousands of study sites across the globe manage their research operations on our platforms. If you’d like to learn more, we’re here to help.