Navigating the Evolving Landscape of Decentralized Clinical Trials
Jonathan Ernst, Vice President of In-Home Solutions at PCM Trials, shared his insights on the evolving landscape of decentralized clinical trials (DCTs) in a recent interview. Ernst discussed the challenges, opportunities, and strategies involved in integrating DCT elements into modern clinical trials and how PCM Trials is pushing to expand equity and accessibility in clinical research.
Watch the full interview below or continue reading to explore key takeaways on the role of DCTs in expanding clinical trial access and enhancing participant experiences.
DCTs and their role in modern clinical trials
Decentralized clinical trials (DCTs) are transforming the way clinical research is conducted, creating new opportunities to reach traditionally underrepresented and diverse populations. According to Ernst, DCTs offer the flexibility that is critical in today’s research environment, where the ability to conduct trials outside of traditional settings is increasingly valuable. By incorporating elements such as mobile visits and community-based sites, DCTs reduce the burden of participation by bringing trials directly to participants – whether in their homes or convenient local settings.
Harmonizing the DCT Experience for Participants
PCM Trials is at the forefront of harmonizing the DCT experience, incorporating various decentralized elements in a multi-faceted approach to enhance the overall trial experience for both participants and sponsors alike. A key part of this effort is the strategic acquisition of EmVenio Research, which Ernst highlighted as a deliberate step to create a seamless participant journey.
“We’re trying to stitch all of [these DCT elements] together to create a very accommodating patient journey that allows us to execute clinical protocols with precision,” Ernst noted. This holistic approach not only promotes equitable access through optionality in clinical trials but also ensures that findings are broadly applicable and reflective of a diverse participant base.
Leading the Charge for Diverse and Global Participation
Expanding access to clinical research for traditionally underrepresented populations is a critical goal, especially in light of recent FDA mandates for more diverse and inclusive enrollment in trials. PCM Trials operates in more than 80 countries, providing the infrastructure necessary to bring clinical research to participants in even the most challenging environments.
Ernst discussed the importance of breaking down barriers to clinical trial participation, particularly in regions like healthcare deserts, where access to medical care and research opportunities is severely limited. “What we do to support [the] need for that access to populations is partner [with sponsors early in the study process], and we’re fortunate that our company operates [globally],” he shared. By focusing on these areas, PCM Trials is addressing traditional barriers to clinical trial participation and supporting board-reaching trial access for underrepresented populations around the world.
Overcoming Challenges of Mobile Visits
Executing successful mobile visits within the framework of DCTs presents unique challenges. Ernst acknowledged that the seamless delivery of study protocols in a mobile setting requires meticulous planning and coordination. “We’re talking about having temperature-controlled shipments for blood draws, for example, and meeting a variety of requirements to accommodate the really complicated nature of clinical research,” he shares.
PCM trials addresses logistical challenges by collaborating with experienced vendors and leveraging innovation solutions to ensure that even the most demanding protocol activities can be delivered successfully in a mobile setting.
Encouraging Site Adoption of DCT Elements
The adoption of DCT elements by clinical sites is essential for the continued implementation of decentralized trials. However, the inherently risk-averse nature of the clinical trials industry means that this adoption must be approached with careful consideration. Ernst emphasized the importance of providing site staff and principal investigators with the support and data they need to feel confident in integrating DCT components into their trials.
By demonstrating the value of DCTs as a flexible and patient-centric option, PCM Trials fosters a collaborative environment that balances innovation with careful attention to risk management. “There’s optionality for [the site] and for the trial participant under [the sites’] direction,” Ernst stated, highlighting the importance of presenting DCT components as adaptable and optional, rather than mandatory.
A Future of Accessible and Inclusive Clinical Trials
The integration of decentralized clinical trial elements, such as mobile visits, represents a significant advancement in clinical research. By harmonizing these components and addressing the associated challenges, PCM trials is helping to make clinical trials more accessible, inclusive, and effective. This ongoing commitment to equity and patient-centricity is setting the stage for a future where clinical trials are not limited by geography or demographics but are truly representative of target populations.
For a more in-depth look at how DCTs can improve accessibility to trial participation in underrepresented communities, like those in healthcare deserts, read our latest article here.
And learn more about how PCM Trials can support your clinical development program. Email us at [email protected] or call 303‐253‐7470.
