The Future of DCTs is Bright According to Big Pharma and FDA

The clinical trial industry faces a critical juncture as the dust settles from the COVID-19 pandemic. During the height of the pandemic, decentralized clinical trials (DCTs) and the use of digital health technologies (DHT) emerged as beacons of innovation, enabling research to continue despite global lockdowns. This period emphasized the potential of DCTs to make clinical trials more accessible, efficient, and patient-centric. The FDA, the biopharmaceutical industry, and clinical trial experts predict a movement toward DCT adoption, showing a solid future for DCTs.

The Evidence of Progress in Biopharma

The pandemic era accelerated clinical trials and showcased extraordinary collaboration and innovation across the board. Pfizer’s Rob Goodwin’s revelation at the SCOPE Summit 2024 is a prime example of this shift, with the company dramatically reducing operational cycle times from 8.5 years in 2019 to 5.7 years in 2023, aiming for a target of 3.5 years by 2025​​. This reduction in time reflects not just the urgency of the moment but a comprehensive reevaluation of clinical trial methodologies, leveraging technology and decentralized approaches to streamline processes and enhance efficiency.

This period of innovation was not isolated to Pfizer. Other pharmaceutical giants and biotech firms embraced similar transformations. For instance, Moderna’s expedited development of its mRNA-based COVID-19 vaccine was a watershed moment for the industry, demonstrating the potential for rapid vaccine development and deployment. The use of real-time data analysis, remote monitoring, and digital health technologies became pivotal in navigating the challenges posed by the pandemic, setting new standards for speed without compromising safety or efficacy.

The FDA’s Stance is Unambiguous: DCTs and DHTs Represent the Path Forward for Clinical Research

Drawing from insights shared during a fireside chat at the 2024 SCOPE Summit and DIA town hall, the FDA is pushing for DCT practices in the future. “Our guidance on DCTs is not just a document; it’s a roadmap for the future of clinical trials,” said Jacqueline A. Corrigan-Curay, JD, MD Principal Deputy Center Director, Center for Drug Evaluation and Research at FDA. However, the FDA’s engagement with DCTs extends beyond issuing guidance documents. The discussions highlighted the agency’s proactive approach to fostering innovation in clinical research through the support of DCTs, emphasizing a collaborative effort with industry stakeholders to ensure that the integration of DCTs into clinical research is both practical and secure.

During these discussions, FDA representatives emphasized the importance of adapting regulatory frameworks to accommodate the rapid advancements in digital health technologies that enable DCTs. This adaptation is about maintaining safety, integrity, and compliance with GCP and enhancing the efficiency and inclusivity of clinical trials. The FDA’s commitment to DCTs was articulated as a response to the evolving medical research needs, aiming to make trials more accessible to participants, irrespective of their geographical locations, and to gather more comprehensive and real-world data.

The town hall meeting discussed the FDA’s proactive approach to integrating DHTs into the DCT landscape. Emphasis was placed on how these technologies can improve the efficiency of clinical trials, enhance patient accessibility, and make participation more convenient. There was a clear recognition of the need for regulatory frameworks to adapt to these advancements, ensuring that patient safety and data integrity remain paramount. “We are collaborating with external partners. We are collaborating internally, making such an effort to make sure that… we’re all aligned as we move forward to make it (DCT implementation) easier… using these innovative technologies,” said Marsha Samson, PhD, Analyst, Office of Medical Policy, FDA. The discussion also touched on the FDA’s commitment to addressing health disparities and advancing health equity, reflecting on the Enhanced Equity Initiative.

The FDA’s push for DCTs and DHTs is evident through their proactive policy-making and collaborations. They advocate for these technologies to make clinical trials more accessible and efficient without compromising safety and integrity.

The Intersection of eClinical Technology and DCT Growth

The expansion of DCTs heralds a transformative era for clinical research, with eClinical technology at the forefront of this revolution. Michelle Longmire’s insights into the future of clinical trials highlight the synergistic relationship between DCTs and eClinical advancements. Here’s how eClinical technology is set to benefit from the growth of DCTs:

• Enhanced Patient Accessibility: eClinical platforms, such as Medable’s Total Consent solution, facilitate remote participation, making trials more accessible and improving patient engagement, understanding, and retention.
• Real-time Data Collection via DHTs and Digital Biomarkers: Using digital biomarkers and DHTs, such as wearables, enables continuous data collection, offering rich, real-time insights for quicker, more informed decision-making via a unified platform like Medable evidence generation platform.
• Regulatory Compliance: As regulations evolve to accommodate new technologies, eClinical solutions that ensure compliance will be crucial for smooth trial execution.
• eCOA for Enhanced Data Quality: eCOA platforms, such as Medable’s eCOA+ will support DCTs by enabling remote, timely, and accurate capture of patient-reported, clinician-reported, and performance outcomes, making trials more accessible and inclusive.
• Collaboration and Interoperability: Technologies that support data sharing and integration will be key in a future where collaboration across stakeholders is essential.
• Addressing Health Disparities: eClinical tools can help reach underserved populations, contributing to more equitable health outcomes and patient inclusion.

The alignment of eClinical technology with the growth of DCTs is clear and compelling. As DCTs redefine the clinical trial landscape, eClinical technologies are poised to play a pivotal role in enhancing accessibility, streamlining data collection and analysis, ensuring regulatory compliance, fostering collaboration, and promoting health equity. This symbiotic relationship accelerates the pace of clinical research and broadens its impact, paving the way for a more inclusive and efficient future in clinical trials.

Embracing the Future: The Resurgence of DCTs and DHTs in the Digital Age

The overall outlook for DCTs is positive. The concerted efforts of pharmaceutical companies, regulatory agencies such as the FDA, and industry thought leaders towards adopting DCTs and DHTs highlight a promising horizon for this domain and the undeniable benefits of DCTs—including broader accessibility, enhanced efficiency, and superior patient engagement—stand out. These merits, coupled with the dedication of significant industry players to innovation, herald a robust revival and expansion of DCTs in the years to come.

Additionally, the dynamic progression in eClinical technology is set to be a key driver in this evolution. Integrating DCTs with cutting-edge eClinical solutions and leveraging digital biomarkers, wearable technologies, and instantaneous data capture promises to transform clinical research fundamentally. This transition towards more accessible, streamlined, and inclusive trials, underpinned by flexible regulatory guidelines and a commitment to bridging health disparities, offers a bright outlook. As the sector moves beyond its pandemic-era challenges, the shift to a more decentralized, technology-enhanced clinical trial model emerges as inevitable and a pivotal advancement for the future of clinical research and patient treatment.

This article is sponsored by Medable.