The Past, Present, and Future of Mobile Visits in Decentralized Clinical Trials

The Past, Present, and Future of Mobile Visits in Decentralized Clinical Trials

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In partnership with GlobalData, PCM Trials recently hosted a live webinar that offered a look into the evolution and future of decentralized clinical trials (DCTs). The discussion, led by Ellen Weiss, Emeritus Strategist at PCM Trials, alongside industry veterans Craig Lipset and Deb Guattery, provided a deep dive into the journey of DCTs from their inception to their current state and future potential.

Read some of the key takeaways below or click to watch the entire one-hour webinar.

The discussion opened with a historical overview of DCTs, shedding light on the early days of mobile visits. As Ellen Weiss highlighted the combined efforts that have paved the way for DCTs, Deb Guattery and Craig Lipset chimed in to provide a retrospective look at how DCTs emerged from a niche concept to mainstream methodology. Deb Guattery recounted her pioneering work at Pfizer, where she was instrumental in integrating mobile visits into clinical trials before they became a widespread practice. Craig Lipset, well-known thought leader in the DCT space, also reflected on his journey of integrating technology with patient care, emphasizing the collective efforts through the Decentralized Trials Research Alliance to facilitate the global adoption of DCTs.

Although the idea of DCTs was not novel at the time, the COVID-19 pandemic served as a catalyst for accelerated adoption. There was a dramatic shift in demand for PCM Trial’s services during this time, increasing from 72 RFPs in 2019 to a staggering 881 in 2020. This period marked a pivotal moment, demonstrating the essential role of mobile visits and the rapid implementation of DCTs as a response to the global crisis. Craig Lipset offered insight into the ongoing evolution of DCTs, sharing that “during the pandemic we saw chaotic, frenetic adoption, but now we’re entering a different time,” emphasizing the evolution from emergency implementation to thoughtful integration of DCT methodologies into clinical research practices.

The discussion also touched upon present-day regulatory considerations, specifically the importance of regulatory clarity and the role of agencies like the FDA and EMA in supporting the growing DCT landscape.

Looking forward, the speakers shared their visions for the future of DCTs, stressing the importance of patient-centricity, regulatory support, and technological advancements. They touched on the potential of AI and emerging technologies to tailor patient experiences in future clinical trials. Craig Lipset provided a forward-looking perspective, saying “The future of decentralized trials is not just about industry and whether pharma companies will continue to adopt of not. As long as we have regulatory clarity and we’re listening to patients when we’re planning and designing our studies, these models will persevere.”

Questions from the attendees brought forward both concerns and curiosities about the future of DCTs. One question asked, “How aligned should a sponsor consider the strategies to advance home health and mobile visits with alternative visits?” This sparked a discussion on the integration of various patient-centric strategies and the importance of a cohesive approach to trial design. Panelists also strongly advocated for patient and clinician voices to be at the forefront of evolving DCT strategies. Participants also inquired about the sustainability of DCTs and their ability to stand the test of time. Ellen Weiss expressed optimism, echoing previous sentiments, and emphasizing the importance of seeing patients and their families as central to the research effort.

The discussion concluded with a unified call to action for stakeholders in the clinical trials ecosystem to embrace lessons learned from the past, navigate present challenges with care, and collaboratively work towards a future where DCTs are seamlessly integrated into research practices.