The Changing Landscape of Decentralized Clinical Trials

Decentralized clinical trials (DCTs) have ushered in a new era, fundamentally altering and broadening the scope of clinical research. But this is just the beginning. Traditionally, clinical trials, including DCTs, have been clustered in urban centers, providing abundant opportunities for those within a 50-mile radius of clinics, hospitals, or universities, but missing a substantial segment of the US population residing in remote areas. The participation rate in clinical trials was a paltry 5 percent among Americans in 2021, a figure that falls short of representing truly diverse patients in research. 

Trial protocols need to be designed to prioritize patient convenience and requirements. Embracing advanced technologies, such as drone deployment and artificial intelligence for example, could enable broader reach to patients who would otherwise have reduced clinic access.

The use of multilingual resources and culturally sensitive materials can bridge communication gaps with non-English-speaking participants. Providing accessible tools for health data reporting, such as mobile apps and wearable devices, enhances patient engagement and compliance. Automated reminders and user-friendly interfaces further ease participation, accommodating a diverse patient demographic. However, the reduced physical interaction with patients necessitates robust remote monitoring and data collection systems. Here, CROs will be pivotal because they can offer support that encompasses the gathering of remote data from wearable devices and remote monitoring tools. The integration of technology will facilitate continuous monitoring of vital signs and other health metrics.

Integrating data from multiple sources, including patient-reported outcomes and electronic health records (EHRs), can offer a comprehensive understanding of patient health, improving the capacity to make well-informed decisions. However, the necessity for in-person visits is not consistent across the board; in dermatology trials, for instance, the specific skin condition being studied, and the current phase of the trial may impose restrictions on the feasibility of DCTs. Depending on the endpoints, conditions such as atopic dermatitis, psoriasis, and acne may require face to face assessments because of nuances such as induration and nodule size that photography cannot capture. Similarly, in rheumatology, swollen and tender joint counts may necessitate in-person evaluations. These considerations highlight that while technology facilitates participation, DCTs are not yet universally applicable across all studies.

To truly expand clinical trials out of saturated regions, it will be essential to build trust with underrepresented groups; historical data show disparities in clinical trial participation among non-Hispanic Black individuals and remote communities. For example, only nine percent of Americans receive clinical trial invitations; of these, less than half participate, with even lower participation rates reported among non-Hispanic Black individuals compared to non-Hispanic Whites. 

DCTs must employ tailored strategies, such as collaborating with local healthcare providers and community leaders to foster trust and ensure inclusivity. This approach reflects the broader population’s health needs, and reaches vulnerable demographics previously excluded due to logistical barriers, like the Navajo population, for example, during COVID-19 trials. Continued support for telemedicine initiatives can help bridge the gap in healthcare access for rural and Indigenous communities, and expanding mobile health services can improve healthcare delivery in remote areas.

A comprehensive DCT strategy should include patient-centric designs, updated risk assessments models, and innovative participation methods, coupled with the use of remote data collection. By embracing these methods, DCTs can enhance the diversity and inclusivity of clinical trials, improving the validity of research outcomes and ensuring equitable treatment solutions.