Decentralized Clinical Trials Could Boost Diversity in Research

Educating people about serious health conditions, increasing awareness about the benefits of clinical trial participation, and reducing barriers to study entry – all through a decentralized approach – aims to reverse decades of inequality in academic medical research.

Technology plays an important role, too.

A mobile app developed in part at the University of Miami Miller School of Medicine significantly increased key drivers of participating in a clinical trial among 100 people at risk for diabetes and hypertension enrolled in a randomized trial, said Azizi Seixas, Ph.D., interim chair of the Department of Informatics and Health Data Science and associate professor of psychiatry and behavioral sciences at the Miller School.

The digital app, Precision Recruitment and Engagement of Individuals at Risk for Diabetes and Hypertension in Clinical Trials (PREDHiCT), provides a personalized navigation through the clinical trial journey. Users are aided by individualized content including infographics, articles and videos and other media curated by an artificial intelligence (AI) and physician input.

The idea is to help individuals navigate clinical trial entry and participation and make the process more individualized and convenient, said Dr. Seixas, lead author of a study examining the strategy published in the International Journal of Environmental Research and Public Health.

Everything is done remotely to make the whole process easier and simpler.

“That way we can remove barriers that get in the way of participating in research, particularly for historically underrepresented groups,” Dr. Seixas said. The approach was well accepted by participants, he added, with only two people not completing the study.

The Advantage of Decentralization

Decentralized design, or trials “executed through telemedicine and mobile/local health care providers, using processes and techniques that different from the traditional clinical trial model,” according to the Food and Drug Administration, means people do not have to come to a medical setting to enroll or participate. In the current trial, participants received a Fitbit or used an Apple Watch to track and monitor their steps, exercise and sleep. Feedback on sleep duration and activity helped engage them in the study, Dr. Seixas said.

The study also revealed that greater awareness of clinical trials benefits increased the desire to participate.

“What we found was, if you increase the knowledge of the health condition and how to prevent this disease, people are more likely participate,” Dr. Seixas said. “It was not only about willingness to participate in the study, but we also found that people are more altruistic in wanting to be part of a solution in tackling a disease.”

Inclusiveness in Medications and Therapies

Dr. Seixas also hopes this approach will encourage a wider range of people to be involved in the development of medications and interventions. Historically, that has not always been the case. Statins, for example, are a class of drugs that are widely prescribed to decrease levels of fat in the blood, including cholesterol.

“One of things we know is that a lot of racial and ethnic minorities were not part of that drug development process,” Dr. Seixas said. “When you don’t test a diverse group, you can’t determine what the significant adverse side effects will be for a particular group,”

Diverse trial participation can inform an optimal dose and treatment plan because a combination of treatments is often required to obtain the desired therapeutic outcome. By contrast, people not represented in a trial could experience side effects that prompt them to stop taking the medication and suggest to researcher the medicine is not working, Dr. Seixas said.

Scaling the Decentralization of Clinical Trials

Decentralized study designs like PREDHiCT can be expanded to other health conditions and scaled up to engage more people. Walgreens, for example, recently approached the researchers to collaborate on future trials.

Among the next steps will be refining the decentralized trial model.

“We recognize that there are some significant challenges that people may face that we may not have addressed systematically, such as social determinants of health and digital literacy issues,” Dr. Seixas said.

The researchers also plan to evaluate other approaches, including virtual reality and augmented reality, to increase knowledge, improve adherence or prompt behavioral change from clinical trials. Dr. Seixas’ vision is to see clinical trials as an entry and extension of care.

“The greatest thing is not just getting the person to be part of a study but getting them really interested,” he said. “People want to be part of research because it transcends themselves. That’s their contribution to society.”

Tags: clinical trials, Department of Psychiatry and Behavioral Sciences, Dr. Azizi Seixas, technology