Bringing Research to the Community: The Virtues of Decentralized Clinical Trials
Article Summary
- The Miller School is at the forefront of clinical trial decentralization.
- Dr. Azizi Seixas says a series of current trials make possible participation from historically underrepresented groups and communities.
- These trials are also employing technology like remote participation and data transmission via wearable devices to increase flexibility for participants.
Decentralized clinical trials are having a moment.
Faculty at the University of Miami Miller School of Medicine are doing their part to ensure the university remains on the forefront of current research strategy. The Miller School has five funded studies underway that involve decentralized study design, bringing all or part of the research to people in the community instead of requiring participants to travel to the medical campus.
These and future decentralized clinical trials focus on expanding clinical trials to historically underrepresented groups and communities.
“We’re talking racial and ethnic minorities. We’re talking immigrants. We’re talking rural areas and particularly urban areas where people have different barriers to engaging in clinical trials,” said Azizi Seixas, Ph.D., director of The Media and Innovation Lab and interim chair of the Department of Informatics and Health Data Science at the Miller School.
Leveling the Clinical Trial Playing Field
The Miller School’s unique leadership is outlined in a review and commentary article in the prestigious journal Science. Dr. Seixas, along with Girardin Jean-Louis, Ph.D., professor of psychiatry and behavioral sciences and neurology and director of the Center on Translational Sleep and Circadian Sciences at the Miller School, summarize the state of decentralized clinical trials and highlight benefits, challenges and best practices around the approach.
“These studies can level the playing field,” Dr. Jean-Louis said. “All members of minoritized and marginalized groups can participate.”
The National Institute of Health noticed the Miller School’s expertise in this area and appointed Dr. Seixas to the National Center for Advancing Translational Sciences Steering Committee on Decentralized Trials.
Bringing trial participation to the people is more than just convenient. People with transportation issues or who are unable to get time off to go to a central setting can participate remotely, for example. They can schedule remote televisits, do self-testing via the mail and submit continuous data from wearable devices.
Flexibility is built into decentralized design. Some people may still prefer to come to the Miller School campus for screening, enrollment or participation. Others may not. Hybrid designs accommodate all preferences, with some in-person and some remote visits.
“It’s really up to the individual and the study,” Dr. Seixas said. “Decentralizing research is a way to put participants and patients at the center.”
Trial Efficiency and Diversity
The wider net cast by decentralized clinical trials can recruit a more diverse group of participants. Recruitment should be faster, as well, shortening the timeline of studies and saving research money. In the Science paper, Dr. Seixas and Dr. Jean-Louis point out that only about 5% of people eligible to participate in studies actually do so. They’re looking to improve on that figure.
Continuous monitoring through wearable devices means more accurate information gathered over time. Decentralized clinical trials can offer more “real-world data” than traditional studies, which are more like a snapshot.
To achieve this, Dr. Seixas and colleagues created a Remote Health Monitoring Solution. The kit includes smart watches, a smart ring, an ambulatory blood pressure monitor, a smart scale and a device to measure air quality.
Potential limitations outlined in the paper include trusting people to be capable of self-testing, such as taking a buccal swab correctly and returning it via mail in a timely manner. Adherence to the study protocol can also be challenging when participants are remote. Technical issues like spotty Internet or electrical service can also be barriers for some people, but Dr. Seixas said the Miller School trials address potential problems.
“We remove all of those barriers and I think that’s what makes what we do unique,” Dr. Seixas said.
“The University of Miami has a great track record on community research like this, which puts us ahead of the curve,” Dr. Jean-Louis said.
The Miller School is a leader in this area because, in addition to collecting volumes of data from multiple sources, Dr. Seixas and colleagues are experts in informatics and big data. They know how to find the best methods for collecting, curating and analyzing data from these trials that could lead to discoveries not possible in controlled, centralized trials.
Tags: bioinformatics, Center for Translational Sleep and Circadian Sciences, clinical research informatics, clinical trials, Department of Informatics and Health Data Science, Department of Psychiatry and Behavioral Sciences, diversity, Dr. Azizi Seixas, Dr. Girardin Jean-Louis