Advancements in Decentralized Clinical Trials: The Impact of AI on Mobile Visits

IMPLEMENTING CHANGE BASED ON PREVIOUS LESSONS LEARNED

The adoption of DCTs over previous decades has been somewhat divisive in the healthcare setting, explained Weiss. However, AI provides a potential solution to the previous barriers and concerns of stakeholders that made implementation so difficult.

From a global perspective, the FDA’s intentions are extremely important. “I’ve been hearing about harmonization for at least two decades,” said Weiss, who supports strategy of decentralized trials for PCM Trials as an Emeritus. “I’m heartened to see a thoughtful plan get produced to put the fundamentals in place for eventual harmonization of the use of AI.”

Within the FDA’s guidance document, four key areas of focus are outlined to support the responsible and ethical use of AI in medical product development: foster collaboration to safeguard public health; advance the development of regulatory approaches that support innovation; promote the development of standards, guidelines, best practices, and tools for the medical product life cycle; and support research related to the evaluation and monitoring of AI performance.

“There’s certainly the appreciation that this is a very long change-curve. But then, there are catalyzing events. The [COVID-19] pandemic was certainly a catalyzing event for the adoption of decentralized trials,” said Lipset. To seize opportunities brought forth by the pandemic, such as utilizing AI in the DCT space, and ensure responsible and sustainable long-term progress and adoption of DCTs, stakeholders must examine lessons learned.

“When I think about DCT adoption over the last three years, there was a frenetic pace which drove a lot of challenges for different vendors—primarily around different technology platforms—that made things difficult for sponsors,” said Lipset. For example, collaboration with investigators and research site staff lagged due to a sprint to deploy tools to sustain trials throughout the pandemic.

Lipset also shared his concerns regarding previous patient-centric approaches to clinical research. “I think it’s easy for us to deploy decentralized approaches in ways we can rationalize as being patient-centric but may not be in the eyes of a patient,” he said. Without patient-centricity, for example, patients are left isolated and lack proper education to use the technology and resources necessary to carry out DCTs. Lipset reminded that technology leverages the opportunity to support patients and make them feel more connected or supported, and commitment by all stakeholders to carefully use AI to deliver sustainable patient-centric models is essential to creating positive change.

Response to technology enablement through a decentralized approach, such as during the pandemic, resulted in a substantial shift forward in terms of capability, highlighted Kelly. But the instance also shed light on the complexities associated with deploying technology out into the field.

“Shifting into this new era of AI enablement brings [with it] an entirely new set of challenges to the on-the-ground implementation and adoption [of DCTs],” she explained. During a time for which technology is advancing quickly, stakeholders must remain adaptive to changes and new challenges without losing sight of the patient participating in the trial.

GETTING THE FUNDAMENTALS RIGHT

PCM Trials, a mobile research supplier, builds a foundation of excellence within standards and processes that can be consistently referenced and adhered to in order to support sponsors and CROs. The supplier is committed to ensuring that all digital technologies are tested for validation and must fulfill requirements of stringent regulatory environments.

“Data acquisition is at the core of what we do,” highlighted Kelly. “Ensuring that any technology that we deploy, in the end, is resulting in the ability to obtain reliable data, reliable information, while at the same time ensuring patient safety is at the heart of all technology deployments.”

From a global standpoint, patient safety and data integrity remain the core focus within the clinical research space. However, with so many different stakeholders involved and because of the complexities associated with the utilization of various operating models, scaling and operationalizing processes in a cost-effective way is challenging.

“We have to have our fundamentals right. But as we think about, also, this desired future state we want to create, [we must think about] who will be the players that start to step in and manage logistics on the back end,” advised Lipset.

Taking anticipatory action and envisioning its future as an independent supplier, PCM Trials recently acquired EmVenio Research, the largest provider of community-based clinical trial sites served by mobile research units. “We were able to go out to our eco space and envision a future where all of these attributes can be responded to,” Weiss commented.

COLLABORATION AND GLOBAL HARMONIZATION

The focus on global harmonization of DCTs and collaboration between regulatory stakeholders is improving, explained Lipset. However, it is important to demystify previous beliefs about how DCTs are conducted and ensure that all perspectives and cultural beliefs are considered.

“I always want to be mindful and respect the fact that there are many in our community that are very fearful of these terms. eSource seems intimidating. DCT seems daunting. AI seems frightening,” said Lipset, who explained that extreme use cases that don’t paint a real picture but, instead, prevent opportunities that can create meaningful improvements to processes. “I want to encourage those whose minds gravitate to the most extreme scenarios to just try to take a step back and think much more incrementally, because that’s the path of progress and change.” Lipset highlighted that AI and new technologies should be encouraged if data is supported with processes and transparency.

Regulators from around the globe are attending annual meetings, such as DTRA 2024, and are sharing perspectives that can fuel collaboration and the development of more harmonized guidance.

“It’s interesting. When you look at the FDA’s draft guidance on DCTs, there’s certainly a lot of thoughtful perspective there. [For example,] what about the role of healthcare providers supporting routine care activities? But when you look at the recommendations paper from Europe on DCTs that published in December, before the FDA’s [paper], there is a very heavy focus on investigator oversight, investigator control, and respect for the role of the investigator. How do we, as global operators, make sure that we are listening to all these perspectives when we’re considering our global strategies? They provide some different areas of focus that we need to be mindful of when we’re planning our global strategies,” said Lipset.

Lipset highlighted the launch of DTRA Circles as beneficial to increasing collaboration between global stakeholders. The DTRA Circles initiative provides stakeholders the opportunity to come together on a more regular basis via monthly or quarterly meetings and collaborate regularly about DCTs through an online social platform.

To successfully embed technology into the DCT space, “Absorption is absolutely dependent on the environment in which it is being conducted within,” added Kelly. “The adoption rates and comfort of embedding new technology into the way we execute processes is very tied to the individual and biases that are within a particular lens, viewpoint, etc.” Ultimately, Kelly continued, execution of DCTs will be dictated by regional and local interpretation and preference. Therefore, all cultural perspectives must be considered.

FUTURE OPPORTUNITIES FOR AI AND DCTs

In terms of opportunities where AI can be useful in clinical research, such as to support DCTs, Lipset highlighted its potential to improve patient support and to equip investigators with better oversight tools for increased visibility of protocols that ensure compliance and patient safety. The data being collected with AI and machine learning tools is already being presented in front of regulatory authorities and regulators are agreeing with approaches being taken to leverage IA to conduct DCTs and collect data, he commented.

“This, to me, is the first step around what we think of as harmonization,” said Lipset. Lipset explained that more understanding around how AI works and its use in training other technologies will eventually lead to a natural evolution of revised best practices.

“I see so many of the immediate benefits [of AI],” said Kelly. “We’ve all been adapting, or the vast majority have, to things like ChatGPT, generative AI, which is having a substantial impact on back-end processes, day-to-day activities, that are sometimes challenging. The efficiency of these technologies frees us to be able to dedicate our time, energy, etc. to focus on actual human interaction,” allowing for optimal patient-centric care.

In addition to creating an impact on patient-centric care, AI has the potential to transform data aggregation and analysis. AI can be employed to pull together data sets that can communicate with each other via technology, explained Kelly, highlighting that the burden associated with analyzing results can be reduced and can have a real impact on day-to-day business.