Global Clinical DevelopmenInc. [NASDAQ: RARE]

The idea of patient-centered healthcare has been around for decades. Patient centricity is thought to foster engagement by including patients in decisions about their care and helping to remove barriers for better health results. Advances in digital health technologies, like wearable sensors, have expanded patient-centric care, enabling researchers to monitor patients remotely and accelerating the use of decentralized clinical trials. But, until recently, this type of trial still was not widespread.

In 2020 the COVID-19 pandemic triggered a global health emergency, along with quarantines, social distancing, and fears of spreading the virus. The pandemic also forced onsite clinical trials to come to an abrupt halt. By April 2020, new participant enrollment in clinical trials fell by nearly 80% compared to the previous year.

To continue their critical work, researchers and study sponsors adapted and began to use decentralized models more often. And the Food & Drug Administration (FDA) loosened regulations to allow researchers to collect trial data remotely outside of in-person research sites.

“The world has become a global, interconnected research arena,” says Dr. Shaheen Lakhan, a board-certified Neurologist, pain management physician, and chief medical officer at Click Therapeutics, a New York-based biotech company. “Patients can be in the comfort of their own home, use technology, whether it's as basic as a mobile application or a website; enroll in the study, read all about it, learn about the implications, and then carry out all of the activities remotely.”

In late 2022, the US Congress approved the Consolidated Appropriations Act, 2023, a $1.7 trillion spending bill that funds the U.S. federal government for the 2023 fiscal year. The bill includes funding for more diversity in clinical trials as part of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Diversifying Investigations Via Equitable Research Studies For Everyone (DIVERSE) Trials Act.

The FDA will hold public workshops to obtain feedback from drug sponsors, patients, and other stakeholders, and to discuss ways to increase the enrollment of historically underrepresented groups in clinical research. FDA’s workshops will also examine the use of decentralized trials and digital health tools, which have grown since the start of the COVID-19 pandemic, and more specifically, will explore how decentralized trials have affected access to clinical trials in underrepresented racial and ethnic groups.

Decentralized clinical trials utilize technology and processes to allow participation beyond traditional research sites such as universities or hospitals. They enable trials to take place virtually, delivering study drug directly to a patient’s home and using digital tools such as electronic consent forms, sensors or connected devices to collect data. The goal is to make clinical research more patient-centric and inclusive.

It is estimated that 70% of potential clinical research participants live two hours or more away from research sites. Decentralization makes it possible for more underserved populations to participate in clinical trials, including those with geographic barriers. Bridging the location gap opens up clinical research opportunities to a larger, more diverse pool of participants, such as people who are frail or immune compromised and those with childcare, work, or transportation constraints.

“How can we create options, choice, and flexibility for people to meet them in the environment that works best for them?” says Craig Lipset, an independent clinical research advisor and co-chair of the Decentralized Trials & Research Alliance (DTRA). “While the location could be in the home, it could be anywhere away from a traditional research site that’s most accessible for people in their everyday lives.”

“The FDA will hold public workshops to obtain feedback from drug sponsors, patients, and other stakeholders, and to discuss ways to increase the enrollment of historically underrepresented groups in clinical research.”

Although a decentralized clinical trial can be fully remote, most researchers use a hybrid model where patients are sometimes required to be physically on-site. As digital health technologies become more intertwined with clinical research, investigators must consider the impact on those individuals with limited access to these tools or the skills needed to use them. Unequal access to the internet, or the digital divide, disproportionately affects Black and Hispanic communities.

According to a survey by the U.S. Census Bureau, around 78% of white households have a broadband subscription, but this number drops to 69% of Hispanic households and 63% of Black households. Health experts now say disparities in broadband internet access should be recognized as a social determinant of health because they impact the health of people and communities.

Decentralized clinical trials may rely on internet access for virtual visits, mobile applications, or connected devices, deepening existing racial disparities in clinical research. “Expecting that people have access to enabling technologies, data plans, and are comfortable with whatever additional requirements go along with it could certainly be a problem,” Lipset says.

While most clinical trial sponsors do not provide home internet access, they typically supply the devices used to carry out remote research, which can help ease the burden on participants. But even devices, and the apps created for them, can introduce bias into clinical research. For example, iPhone users are more likely to be higher-income, educated men.

“You’ve got to factor in all of these biases when you’re recruiting a generalizable, representative population,” Lakhan says. Digital health companies that don’t do this are “reinforcing stereotypes in their algorithms.”

The federal government is addressing gaps in broadband internet access and affordability, providing $65 billion as part of the Infrastructure Investment and Jobs Act.

Lipset cautions that although internet access and decentralization make clinical research more accessible, they are not silver bullets, especially for people already wary of it.

“Decentralized doesn't bring trust. It just helps to mitigate some of those additional access barriers that stand in the way,” he says. “Only after you've got trust can decentralized then be a tool to help address the follow-on barriers around access.”

Bio: Dr. Olugemo is a Neurologist devoted to healthcare advocacy and professional development. She completed her MD training and Neurology Residency at the University of Maryland School of Medicine in Baltimore, Maryland, US, and an additional Fellowship in Neuroimmunology & Multiple Sclerosis.

Over her two decades in clinical research and patient care, Kemi has been involved in community education, patient advocacy, all phases of drug development, global medical strategy, and innovations in lifecycle planning.

Kemi draws on a diverse set of experiences, including being the current Director of Communications at Women of Color in Pharma (WOCIP), serving on the Scientific Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM), Leadership Council of CNS Summit, and founding a healthcare nonprofit organization called Zebulon Foundation, Inc.

Her current role at Ultragenyx Pharmaceutical is focused on developing life-changing medicines for rare and ultra-rare diseases.