Contributed Commentary by Andrea Bastek

July 23, 2021 | With sponsors like IQVIA, Pfizer, and GSK joining the Decentralized Trials & Research Alliance and the FDA giving decentralization its nod of approval, it’s safe to say the clinical research industry will continue to embrace decentralized trials. Decentralized clinical trials don’t just mean fully remote trials, though those are an option—DCTs can also follow a hybrid model, where data collection happens both at research sites and remotely.

But as decentralization becomes more popular, sponsors, research sites, and patients confront an important question: do decentralized clinical trials work? After more than 10 years in the clinical research industry, I believe that decentralized clinical trials not only work but come with an array of benefits for patients, sponsors, and investigators. Here are 5 of the ways a decentralized method helps clinical trials:

Makes trials more participant-friendly

Traditional clinical trials require the participant to visit the research center every time the investigators need to collect data. People may have to drive long distances or take off work for appointments, and because the appointments are focused on data, clinical research staff may not have time to give participants one-on-one attention.

Decentralized clinical trials allow participants to share their data through wearable technology, mobile apps, or telehealth visits without leaving their home or workplace. When participants do need to visit the research site in person, clinical research staff can focus on providing individual advice and treatment instead of just gathering data. This personalized treatment is critical for patients with an illness, who often sign up for clinical trials to receive extra time with investigators and clinical trial staff.

Increases the diversity of participants

Making it easier for people to join clinical trials can greatly increase trials’ diversity, which ensures treatments are effective for a wide range of patients. Although decentralized trials alone won’t lead to full inclusion for underrepresented patients, these trials can help reach patient populations who are often ignored. For example, the ACRP says that 34% of the U.S. population is Black, but only 5% of trial participants are. Similarly, Latinx people make up 18.1% of the population and only 1% of trial participants.

This lack of diversity has a variety of causes, but a major one is access. Academic medical centers often lie in the center of large cities. The ACRP hypothesizes that people who live far away from these research sites often don’t know about or can’t reach clinical trials, and the patients who live nearby may or may not be diverse. Remote technology can widen the pool of potential clinical trial participants, allowing more diverse patients to join.

Remote or hybrid trials are also more accessible for low-income patients. People who rely on public transit may not be able to get to a research center in person, and workers with hourly jobs often can’t afford to leave for appointments. Mobile apps and wearable technology let these candidates share their data with researchers without having to miss work or struggle to reach the research site.

Generates large amounts of data from a variety of environments

In a decentralized trial, investigators can use technology to collect data when participants are at home, at work, or at the grocery store, not just when they visit the research site. Some decentralized trials include wearable devices, while others rely on smartphone apps or telehealth calls.

All of these forms of technology can send data from outside the controlled environment of the research center. This makes the patient data from the trial more varied as well as more accessible to researchers. Investigators can receive data as often as they need it and see how treatments affect patients in a wide range of situations. Remote technology also prevents loss or inaccurate reporting of data. For example, a device could transmit a patient’s heart rate or temperature directly to the research site so the patient wouldn’t have to worry about forgetting to record it or recording it incorrectly.

Helps trials recruit and work with participants efficiently

Recruiting participants can be one of the most time-consuming steps in a clinical trial. Joseph Munda of First Analysis notes that around 50% of clinical trials need to extend their recruitment periods, and 37% of sites never meet their enrollment targets. This can lead to delayed study completion, failure to obtain regulatory approval for the study results, revenue losses, or research sites not being chosen for trials due to poor past performance.

Remote technology expands the pool of eligible participants beyond people who have already visited the research site and allows patients who live hours away to participate in studies. This makes it much easier for investigators to meet both medical and diversity criteria for their trials. Once the trial has all of its participants, decentralized technology can help clinical research staff gather documentation and signed forms in a single, online location.

Supports industry collaboration and connection

Ultimately, all clinical trials have the same goal: better treatments and more cures. That means that in the future, the industry will rely on sharing data between systems to reduce duplicate work and decrease trial timelines. Decentralized trial technology makes sharing information between clinical research professionals in different areas or even different countries fast and secure, with no need to use easily compromised methods like email or dropboxes.

For example, sites can choose a remote eRegulatory solution that can share information with their CTMS, their source data, and the sponsor’s eTMF. The site can then set permissions to control what their sponsor is able to view, and the sponsor can log on and see all relevant information without anyone making copies or sending a litany of emails. Clinical trials will run faster when clinical research staff focus on essential trial components instead of on copying, emailing, or filing documents.

Embracing a Decentralized Method for Clinical Trials

Decentralized clinical trials shouldn’t inspire fear in research sites or sponsors. Clinical trials that use compliant, secure remote technology can include more participants from diverse backgrounds, compile more varied data, and run more efficiently.

The key is ensuring decentralized methods serve your clinical trials, so that the focus always remains on helping patients and advancing research.

Andrea Bastek is the Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research with more than 8,000 study sites across 30 countries connected.  She has extensive experience in the clinical trials space for medical devices, including deep collaboration with sites to drive processes that ensure successful study participation. She is committed to finding workflow efficiencies that improve clinical trial execution. She holds a Ph.D. in Biomedical Engineering from the Georgia Institute of Technology. She can be reached at andrea.bastek@florencehc.com.