Contributed Commentary by Sinead Callinan

October 15, 2021 | Traditionally designed clinical trials chronically struggle to enroll representative patient populations that will yield the comprehensive data needed to ensure that a new treatment will be safe and effective for everyone. A 2018 study reported that a staggering 86 percent of study participants are white, while another found that African Americans make up 43 percent of all cases of SLE (systemic lupus erythematosus) but only 14 percent of clinical trial participants. The safety and efficacy of drugs or biologics can vary significantly based on an individual’s sex, race, age, or other traits, so enrolling homogenous populations in studies can result in data gaps that hide serious concerns for underrepresented groups.

Having worked with both patients and sponsors in clinical trials for many years, I’m all too familiar with the wide range of factors that get in the way of trial participation. In particular, distance from large medical centers and lack of information about clinical trials can severely limit access for patients—many of whom would otherwise add crucial diversity and potentially benefit from participation. I’ve been excited to watch decentralized clinical trial (DCT) approaches become more widely adopted because of their potential to democratize access to research. In order to produce the most accurate and reliable data about each new drug’s efficacy and safety, we have to meet participants and under-resourced sites where they are.

Lowering Geographic Barriers

Traditional site-based studies are inherently limited to participants that live within a “reasonable proximity” to a limited set of well-resourced clinical sites. While the specific radius varies, recent industry data shows that 70 percent of potential study participants must travel at least two hours to reach clinical trial sites.

Even at shorter distances, frequent clinic visits can represent a great burden on participants, their families, and caregivers. Additionally, some potential study participants might have a much smaller “reasonable proximity” than others. These may include:

• Participants and families who can’t take paid leave because they work hourly jobs
• Patients with diseases that impact mobility or make travel particularly challenging
• Patients who rely on public transportation

DCT approaches can expand recruitment beyond study centers by reducing the travel burden on participants and their families. While some clinic visits will likely still be necessary—particularly in therapeutic areas like oncology that require infusion therapies—DCTs can reduce the number of in-person visits by introducing the ability to conduct virtual visits, transmit data through sensors, and otherwise share data remotely.

DCTs also often facilitate in-home visits conducted by trained healthcare professionals who operate as an extension of the research site staff. The presence of home health professionals can provide a sense of support for participants, making it less daunting to take part in the study. Home health professionals can also conduct complex procedures in the participant’s home, further reducing the need for in-clinic study visits.

Increasing Awareness

Many people never hear about study opportunities in the first place. In particular, patients located farther from well-resourced, go-to study sites are more likely to be receiving healthcare from clinics with little to no experience with research. Clinicians at these research-naïve sites may not be as up-to-date on trial opportunities, making them less able to point their patients in the direction of studies that can help them.

DCT models can incorporate digital tactics and outreach strategies that spread awareness online and facilitate direct outreach to new sites and clinicians. Doing so unlocks access to new prospective participants and, importantly, enables sponsors to include sites that serve diverse patient demographics.

Enabling Real Change to Recruitment Practices

From a regulatory perspective, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and United Kingdom governing bodies have all placed a strong emphasis on study population diversity in the drug review and approval process. Government reports have highlighted digital tools, such as those commonly applied in DCTs, as useful methods for helping increase patient access to studies.

By adopting DCT approaches, the industry can answer the call of regulatory bodies while making research participation feasible for sites and participants in communities not located near large health and academic centers. Expanding beyond the radii of typical study centers allows clinical trial sponsors to make real strides in conducting truly patient-centric clinical trials. DCT elements such as sensors, virtual visits, and electronic clinical outcome assessments (eCOA) allow sites to deliver a trial experience that is less disruptive for patients and their families.

Ultimately, increasing inclusiveness is a win for all parties involved. Participants receive better access to therapies, research-naïve sites and clinicians receive more opportunities to participate in trials, and sponsors receive better, more comprehensive data based on representative patient cohorts participating in studies. While DCTs are not a panacea, I look forward to seeing new data and insights unfold and reveal how DCT approaches can lower these and other barriers to participation.

Sinead has 18 years’ experience in clinical service delivery, sponsor research governance, CRO and eHealth. Her experience spans several therapeutic areas including oncology, internal medicine and vaccines development. Sinead is a clinically trained and licensed radiotherapist with a bachelor’s degree from the School of Medicine, Trinity College Dublin and a master’s degree in clinical research from the University of London.

Having held patient-facing roles, Sinead brings multiple perspectives to the design, development and implementation of decentralized clinical trials to positively impact the participant experience and enable equitable access for participant populations. This is a central tenet of her raison d'etre with THREAD!

She oversees customer portfolios within THREAD, managing a delivery team of project managers and coordinators. Working with THREAD, Sinead is thrilled to be part of a driving force for change in the digital transformation of the sector. She can be reached at sinead.callinan@threadresearch.com.