Decentralized Clinical Trials Help Level the Playing Field for Health Equity

Health care providers and public health officials in the United States are increasingly aware of the need to ensure health equity. When people of color and other underserved groups lack quality health care and nutrition, they experience poorer health outcomes, including chronic conditions and premature death. In addition to the human pain and suffering, health inequity costs the United States nearly $100 billion annually in excess medical spending.

But health equity is a global concern. Across the world there are people who cannot access or afford quality health care. In many countries, particularly in Africa and Southeast Asia, health inequity impacts much of the population. Even in relatively wealthy nations such as those in western Europe, tens of millions of people cannot access quality health care due to socioeconomic status, race, ethnicity, gender, disability, location, and lack of transportation, factors commonly known as social determinants of health (SDoH).

SDoH not only create barriers to basic care, but they prevent people who are coping with health inequity from participating in traditional clinical trials that could help them with their conditions and pave the way for medical breakthroughs. This is because the old model of clinical trials precluded participation for people living far from the handful of trial locations typically set up for a study, as well as individuals whose jobs, mobility, family obligations, or financial situations made it impossible for them to make repeated visits to a distant trial site.

It is no surprise, then, that research shows more than three-quarters of participants in clinical trials globally are White individuals with higher incomes. People in that demographic, particularly older adults, have more time, flexibility, and disposable income to participate in site-based clinical trials.

Unfortunately, this lack of diversity among trial populations undermines medical research.

“Development of interventions that are not tested in diverse populations can lead to treatments that are less effective and less trusted in some populations, despite their need for the intervention,” write Ashwarya Sharma and Latha Palaniappan, Stanford University School of Medicine, in Nature.

What can pharmaceutical companies, clinical research organizations, and other trial stakeholders do to make clinical trial participation accessible to more diverse populations? The answer lies in technology—specifically, software complemented by services that allow trials to be conducted remotely or through local health care providers.

Though the technology and services powering decentralized clinical trials (DCTs) has been around for more than a decade, adoption of DCTs for medical research was slow until 2020, when the COVID-19 pandemic blew up the site-based clinical trial model and forced researchers to either halt their work or find another way to enable trial participation. From the second half of 2019 to the second half of 2020, the use of DCTs surged by 77%, compared to 7% annual growth from 2014 to 2019, according to an analysis of more than 1000 clinical trials by pharma consulting company ZS.

DCTs Are Here to Stay

While pharma and clinical research organizations embraced DCTs out of urgent necessity as the pandemic devastated site-based trials, the many obvious financial, operational, and clinical benefits of DCTs have ensured they became a permanent and growing part of the clinical trial process.

The patient-centric approach of DCTs makes it easier for trial sponsors to recruit and retain diverse participants because it eliminates geographic barriers that limit the pool of potential study participants. Using DCT platform software, networking technology, and connected devices, patients can enroll and take part in clinical trials without leaving their communities or even their homes.

This means people who are unable to travel great distances to a trial site, those who cannot leave their families for long periods of time, and those who are financially unable to take off time from work now can participate in clinical trials. With DCT technology, any person in the world theoretically could participate in a clinical trial, no matter their personal or financial circumstances, thereby solving many of the pre-existing challenges to engaging diverse populations.

Accelerating Research and Strengthening Data

The medical research and clinical ramifications of decentralized trials are huge. Including demographically diverse groups of participants strengthens the quality of clinical trial research data, which in turn leads to better medications and treatments. Through expanded participation opportunities and their role in the development of safer, more effective drugs, DCTs promote health equity around the globe.

DCTs accelerate clinical research by making it far easier for trial sponsors to attract participants and minimize the number of people who prematurely withdraw from a study. Research published by the National Library of Medicine showed the cost of recruiting a new patient to replace one who dropped out of a clinical trial was nearly $20,000 between 2015 and 2016, or more than 3 times the average cost ($6,533) to initially recruit a participant. Given the approximate 30% attrition rate for traditional clinical trials, it is clear the benefits demonstrated by DCTs can dramatically lower the costs of clinical trials.

DCTs also afford trial sponsors the advantage of flexibility by giving them the option of running a strictly decentralized trial or employing a hybrid model that combines DCTs with site-based studies. The ability to customize their trial design to optimize participation provides pharma and CROs with another way to promote health equity.

COVID-19 disrupted the clinical trial industry and exposed the flaws of site-based studies, flaws that include an egregious lack of diversity. DCTs do not just decentralize trials—they democratize them.