9 Challenges and Risks for Launching Decentralized Trials
Decentralized clinical trials have exploded in popularity. A WCG survey showed that 94% of research sites have adopted at least one decentralized method, and 88% of sites have already hosted hybrid trials that combine remote technology and in-person site visits.
But decentralized clinical trials also come with challenges. To keep clinical trials safe, compliant, and effective, sponsors, CROs, and research sites need to think carefully about the potential risks of decentralized trials and how they will avoid or minimize them.
Here are a few decentralized clinical trial challenges that research professionals should prepare for:
1. Participant accessibility
Decentralized trials should put participants first. And in many ways they do—patients who are coping with an illness often appreciate being able to send data from their homes instead of driving to the research site for every appointment.
Decentralized trials can also serve participants who live hours away from research sites, as 70% of the U.S. population does, and can help hourly workers who can’t take time off for appointments. However, all of these benefits depend on patients having access to smartphones, WiFi, and technology, as Leslie Byatt pointed out in our podcast episode on diversity and inclusion in clinical research.
Patients who don’t have reliable Internet access or don’t understand technology could end up shut out of fully remote trials. That’s why it’s important to embrace hybrid trials and give patients options outside of apps or wearable devices. Some patients may need support from research site staff in person, while others may need to have their data collected at pharmacies, doctors’ offices, or community centers. Flexibility is the key.
2. Research sites being left out of the trial process
As decentralized trials become more popular, some research sites worry that sponsors and CROs will go straight to patients and cut sites out of the clinical trial process. This could create problems for participants who require support and guidance from medical staff, as well as raise protocol concerns. It’s difficult to ensure patients are using devices or medications correctly without the help of site staff.
There’s good news, though: decentralized doesn’t have to mean siteless. Though some companies focus on siteless trials, most sponsors, CROs, and research sites plan to use a hybrid model where decentralized apps or devices are combined with in-person visits to the site. If you want to learn more about how people refer to decentralized trials, this article is a great place to start. How often participants visit the site will depend on the needs of the study and of the participants themselves.
3. Choosing the right technology
Decentralized clinical trials require technology that can quickly transfer data from wearable technology or remote locations to research sites and then to sponsors and CROs. But sites, sponsors, and CROs might have trouble finding secure, private technology designed for decentralized trials.
No one wants to run the risk of exposing patients’ private health data during a decentralized trial. That’s why it’s important to avoid email and shared online drives and only invest in technology that meets FDA CFR Part 11, GDPR, and HIPAA requirements.
The software vendor you choose should be able to answer any questions you have about privacy and security. They should also be able to show you documentation about how they remain compliant with national and international clinical research guidelines (we keep ours on the compliance page of our website.)
4. Cost of new software
In the 2021 Florence State of the Industry Survey, 68% of research sites, sponsors, and CROs said they worried about the cost of new technology. A study conducted by Ken Getz of the Tufts Center for the Study of Drug Development also showed that unclear return on investment (ROI) was the number one concern about investing in technology for most organizations.
Technology will usually require a large upfront investment. But you can make that investment more palatable to your organization’s leaders by talking to software vendors about the ROI their other customers have seen.
Ask for case studies, customer testimonials, referrals, or ROI documents from organizations like yours. These documents should demonstrate how the software makes clinical trials more efficient, leading to long-term savings in spite of the software’s initial cost.
5. Clinical research staff learning new technology
The Tufts study showed that, in addition to worrying about how much technology will cost, many research organizations worry about how long it will take to implement new tech. Clinical research professionals often have busy schedules and limited time to learn software programs.
You can encourage technology adoption by choosing user-friendly software. But even intuitive programs require an implementation process and excellent customer support. Before you buy technology for decentralized clinical trials, ask the tech vendors what their implementation and training programs look like and what customer support they provide after the implementation stage is complete. You want a partner who will make sure your team is comfortable with the technology, not one who will leave you on your own as soon as you buy their tech.
6. Participants learning new technology
Clinical research professionals aren’t the only ones who might have to learn new technology during a decentralized clinical trial. Participants may also have to operate wearable devices or smartphone and computer applications. This can make decentralized trials more complicated, since even participants who have easy access to WiFi and computers may not feel comfortable using unfamiliar software.
Having user-friendly software can help participants just as it helps clinical research professionals. Vendors should also teach a few clinical trial team members how to share their knowledge with patients.
Hybrid clinical trial models can also make participants more comfortable with tech. If participants visit the research site in person for orientation or appointments, clinical research staff can check if they’re using their devices or apps correctly and answer any questions they have.
7. Accidental protocol deviations
Decentralized clinical trials have a much higher risk of protocol deviations than traditional centralized trials. Although coming to the research site for every appointment isn’t convenient for patients and leads to less data being collected, it does ensure that research protocols are followed precisely.
When patients send their own data from home, work, or school, there’s a higher risk that they could use a device wrong or record their data incorrectly. One solution is to use a localized trial model rather than a fully remote one. Instead of only relying on technology, patients may be able to check in at local doctors’ offices or pharmacies when they need data recorded.
Research sites could also give patients thorough training on how to use apps and wearables according to the study protocol. Some clinical research organizations even invest in devices that record data and send it straight to the research site so that patients won’t have to worry about writing or typing their data incorrectly.
8. Accounting for flexibility
One of the greatest benefits of decentralized clinical trials is flexibility. Patients can record data while they’re at work, grocery shopping, or at home, not just while they’re at the research site. On our podcast episode about decentralized trials, Amir Lahav of Mitsubishi Tanabe Pharma Holdings America explained how this flexibility can encourage patients to participate in clinical trials.
Collecting data from a variety of environments can even give clinical trial staff a more accurate picture of how a drug or device works in real life. But this flexibility also means that a patient’s health data might vary depending on the environment they’re in.
Research staff could see differences in blood pressure because of stress from work or temperature fluctuations because of weather. Your study protocols will need to account for how different environments may impact your data and the conclusions you draw.
9. Too much data
Decentralized methods allow clinical trial staff to collect patient data frequently and in a variety of environments. But the amount of data coming in can be overwhelming. If staff have to spend hours sifting through data points or transferring them between different systems, decentralized clinical trials could become more complicated and time-consuming than traditional ones.
To overcome this challenge, clinical trial professionals need to search for software that can collect and organize data automatically. Integrations that transfer data between programs can make a big difference here. For example, some electronic data capture (EDC) programs can integrate with electronic Investigator Site Files (eISFs) so the clinical research team doesn’t have to worry about manually transferring data from one to the other.
It’s easiest to pull off integrations when your clinical trial software has an open API. You can learn all the details about what an open API is and how it works from our guide, but essentially, an open API allows you to integrate software from multiple vendors so you can keep all your data in one place.
Prepare for the Challenges of Decentralized Clinical Trials
Decentralized clinical trials come with an array of benefits: flexibility for patients, more data for clinical research staff, and the inclusion of patients who live hours away from research sites. However, decentralized trials also come with a variety of challenges.
For research sites, sponsors, and CROs to run successful decentralized trials, both patients and clinical trial staff need to understand and have access to technology. Clinical research teams also have to design flexible yet effective protocols and make sure they can manage all of the data they receive.
The good news? Many clinical research professionals have already proved that with intuitive technology and innovative thinking, they can overcome these challenges and build effective, flexible decentralized trials.
For more information on how clinical research teams are preparing for the future of decentralized clinical trials, check out our decentralized clinical trials for research sites eBook.