As the clinical research landscape evolves, the need for innovative trial designs that prioritize flexibility for patients and incorporate components to expand accessibility has never been greater. Traditional site-based study models, while effective in many contexts, often undervalue the logistical and geographic barriers that prevent many patients from participating. This is where decentralized and hybrid designs can make an impact.
At Elligo Health Research, we’re at the forefront of implementing these innovative approaches. By leveraging our experience as a site network and conducting fully virtual/remote studies, we can expand access to underrepresented populations and create more inclusive trials.
The Case for Hybrid and Decentralized Trials
The definition of decentralized clinical trials (DCTs) has broadened across the industry in recent years. Where we used to only consider technology, telehealth and remote monitoring as DCT elements, we now include virtual screening visits, mobile phlebotomy and mobile nursing, ePROs, direct to patient drug delivery and more. All of these elements contribute to reduce the burden on participants to travel and attend visits and complete study requirements. Hybrid trials combine the best of both worlds, incorporating both on-site and virtual components. These models are particularly beneficial for reaching populations that exist outside the geography of established treating physicians and experienced research sites, providing a path to participation that otherwise would not be physically possible.
For example, digital marketing and recruitment technologies allow us to connect directly with potential participants in rural and/or underserved areas. Virtual/telehealth screening and home-health visits enable patients to contribute to research from the comfort of their homes and on their schedule. This not only reduces logistical challenges but also helps build trust by demonstrating our commitment to patient-centricity and meeting participants where they are.
Partnering with Trusted Community Physicians
One of our key strengths as a research community is our ability to work with trusted physicians who are embedded in their communities. These doctors already have established relationships with their patients, making them ideal partners for introducing clinical trials as a care option. This trust is critical, particularly when engaging with populations that have historically been excluded from research.
With Elligo’s combined and unique experience as a site-network and managing DCT studies, our partnerships and knowledge of community-based recruitment allow us to design trials that are tailored to the needs of specific communities. Whether the focus is on socio-economic diversity, gender representation, or age inclusivity, we collaborate closely with sponsors to devise strategies to ensure that each study meets its overall and diversity objectives.
Looking Ahead
Decentralized and hybrid trials are more than just logistical solutions—they represent a commitment to patient-centric research. By prioritizing accessibility and inclusivity, we can ensure that clinical trials reflect the populations they aim to serve. This focus not only aligns with regulatory expectations but also enhances the scientific validity of research findings.
At Elligo, we’re committed to breaking down barriers and expanding access to clinical trials. Together, we can create a future where the patient’s experience is supported by design and clinical research participation reflects the diversity of our population.