New era of technology brings unique obstacles.
Decentralized clinical trials (DCTs) could bring cutting-edge medical treatments to more patients than ever before. Patients who can’t travel to academic medical centers can now join many trials from their homes or from local clinics and pharmacies.
Overall, the clinical research industry has embraced DCTs. As of 2021, 95% of research sites use at least one form of decentralized technology. DCTs also allowed Pfizer, Janssen, Moderna, and Astra-Zeneca to test their COVID-19 vaccines.
COVID-19 accelerated technology adoption and challenged the status quo in clinical trials. The adoption and support of DCTs is part of that paradigm shift.
But some patients feel anxious about using new technology. Research sites and sponsors also worry about whether DCT technology will be affordable, secure, and able to integrate with their existing systems.
For decentralized clinical trials to achieve their full potential, research sites and sponsors need technology that can get up and running quickly and that works for physicians, clinical researchers, and participants.
Here are a few challenges that come with decentralized trial technology and tips for how your research team can overcome them.
To make decentralized clinical trials fast and effective, research sites need to have technology in place before each trial begins. If sites have to learn new software for every trial, the already-long study start-up process becomes even longer.
Start-up delays cost sponsors thousands of dollars, cause sites to miss their study deadlines, and slow down the process of getting drugs to patients. This is just one example of the ripple effect that inefficiency can create.
But 68% of research sites worry about the cost of new technology. A study from the Tufts Center for the Study of Drug Development showed that unclear ROI was most organizations’ number one concern about technology.
Ideally, sites would choose and set up their own clinical trial software that they use for all (or almost all) of their studies. The site staff could then win studies by showing sponsors that they already have the technology to run decentralized trials.
This technology adoption is what a sponsor wants to see, because it shows that the site can handle remote monitoring and run an efficient, innovative trial. However, adopting technology is only one piece of the puzzle. In order to maximize their return on investment (ROI), an organization should compliment technology adoption with process improvement.
Your software vendor should help you with this process by providing case studies or testimonials about the ROI their other customers have seen. With 97% of sponsors now using some form of decentralized technology, having an effective technology infrastructure will help your site remain competitive and win studies, leading to a high ROI.
In addition to worrying about how much decentralized trial technology will cost, clinical research teams often worry about how long it will take to implement new tech.
One-third of Clinical Research Associates said that the technology they use isn’t intuitive, and two-thirds said they didn’t receive enough technology training to efficiently do their jobs.
To make decentralized trials successful, research sites and sponsors need to choose user-friendly software. But they also need to choose software vendors who offer a thorough implementation process and extensive customer support.
Decentralized clinical trials also don’t work well if physicians at academic medical centers and local clinics aren’t willing to use the technology. Many doctors already find clinical trials stressful—more than half of new investigators said they wouldn’t run a second trial.
Therefore, it’s important that decentralized clinical trial software has physician-friendly features. Investigators need to log onto a software program or app and instantly see which tasks they need to complete and which forms they need to sign.
If you’re choosing DCT software for your site team, make sure you search for intuitive, physician- and staff-oriented software.
Because traditional clinical trials often take place at academic medical centers (AMCs) in major cities, they frequently suffer from a lack of diversity.
Decentralized clinical trials can bring cutting-edge treatments to patients in rural or impoverished areas and to patients who can’t afford to take time off or travel to AMCs.
However, sites and sponsors attempting decentralized clinical trials need to acknowledge that some patients don’t have access to smartphones or computers. Even if research sites supply patients with phones, tablets, or wearable devices, the patient may not have reliable Internet access.
This is why decentralized clinical trials can’t rely solely on technology. Some patients may do all of their check-ins via phone or computer, but others may need to visit neighborhood clinics or pharmacies to have their data collected.
Even participants who have access to technology may not feel comfortable using electronic patient diaries or ePRO software. With hybrid trials, participants can sometimes check in from work or home using technology. But at other times, they can visit the research site or a local doctor’s office to learn how to use DCT apps correctly, ask questions, and undergo testing.
With the rise of regulations like GDPR and CCPA, research sites need to think carefully about how to protect patient data during decentralized trials.
Although it’s easy to share patient documents through online drives or email, these methods aren’t always secure or compliant with GDPR, HIPAA, and regulations from national bodies like the FDA or EMA.
Many decentralized trials also rely on investigators and participants signing forms online. If you’d like to take advantage of those capabilities, it’s especially important to look for software that complies with your country’s regulations around eSignatures.
In the US, that means finding software that complies with FDA 21 CFR Part 11.
If you’re looking for new clinical trial technology, ask potential vendors whether their software complies with all national and international clinical trial standards. You should also ask which cybersecurity policies they have in place to protect patient data.
Decentralized clinical trials often rely on patients recording their own data at work or at home, which can increase the risk of protocol deviations. A participant might wear a device wrong or record their data incorrectly in their electronic patient diary.
Research sites can use a few methods to keep data accurate during decentralized trials. First, research site staff can give patients thorough training on how to use all apps, software programs, and wearables.
Clinical research organizations can also rely on devices that automatically record data where possible. Although participants will still need to know how to wear the sensor or device, research professionals won’t have to worry about participants recording their data incorrectly.
Finally, research sites can embrace hybrid methods where participants check in at local pharmacies, labs, and clinics. The local facility can then record the patient’s data according to the study protocol and use software to send it to the research site.
Decentralized clinical trials can produce far more data than traditional, site-based trials. In a traditional trial, clinical research teams can only collect data from patients when they visit the site in person every few weeks or months.
With decentralized clinical trials, sites can receive data from patients electronically on a daily basis. Decentralized trials also help investigators see how a drug works in a participant’s everyday environment. The technology meets the participant where they live, and that produces insights that can’t be gained in a traditional setting.
But this flexibility also means that a patient’s health data might vary depending on the environment they’re in. Investigators could see differences in blood pressure because of work stress or temperature fluctuations because of external weather.
Your study protocols will need to account for how different environments may impact your data and the conclusions you draw. Your protocols will also need to account for the tremendous amounts of data flowing in from different software programs during a decentralized trial.
About two-thirds of clinical research professionals say they already have to perform duplicate data entry because their software programs don’t speak to one another.
With more data coming in because of decentralized trials, duplicate data entry becomes even more time-consuming and unsustainable. This is where technology integrations can help.
Clinical research professionals need integrated software programs that can automatically share data with one another. For example, some electronic data capture (EDC) programs can integrate with electronic Investigator Site Files (eISFs) so the clinical research team doesn’t need to manually transfer data from one to the other.
Some software vendors will build manual integrations between CTMS systems, eISFs, and data capture programs like EDCs, ePRO, or eCOA. But to make technology integrations possible, you need clinical trial software with an open API.
Software with an open API is capable of integrating with technology from other vendors. By contrast, software platforms with a closed API can only integrate with programs from the same manufacturer.
Closed APIs force research sites and sponsors to either give up on integrations or buy eISF, EDC, eTMF, or CTMS platforms all from a single provider, even if that provider’s software isn’t best-in-class for every category.
A lack of integrations leads to repetitive, time-consuming work, while being forced to use software from a single provider leads to inefficient, difficult-to-use technology.
In the words of former FDA Commissioner Scott Gottlieb, MD, the industry needs to "develop new incentives that reward collaboration and data sharing across the clinical research enterprise.” Open APIs and well-integrated software play a critical role in making data-sharing across platforms possible.
Decentralized clinical trials won’t run nearly as efficiently without the benefits of well-integrated technology.
Decentralized clinical trials can provide promising medical treatments for underrepresented patients across the world. But this vision won’t become reality until clinical trial professionals have access to secure, well-integrated software that’s easy to use for both staff and participants.
Research sites, CROs and sponsors need to look for this technology now to make decentralized trials safe, fast, and efficient in the future.
Marc Leighton is Florence Healthcare’s VP of Product