In today’s discussion, we’re joined by Craig Lipset, Co-Chair of the Decentralized Trials & Research Alliance (DTRA), who shares his insights on the evolving landscape of government involvement in decentralized clinical trials (DCT). Craig offers a detailed perspective on how various government agencies intersect with DCTs, their objectives, and the potential outcomes of their investments, providing an illuminating overview for our clinical trial community.

Moe Alsumidaie: Craig, there seems to be a growing interest from government agencies in decentralized clinical trials. Can you explain why these agencies are involved and what they aim to achieve?

Craig Lipset: Certainly, Moe. Government agencies in the United States, particularly the FDA, embrace decentralized clinical trials to support innovation and avoid being a bottleneck for progress. They’re not only receptive to new approaches but also focus on ensuring they fit within existing regulatory frameworks. Agencies like the NIH seek to integrate these technologies into their research endeavors to improve access and outcomes. For instance, the FDA’s Oncology Center of Excellence advocates for improving access while adhering to safety and data integrity, whereas the Digital Health Center of Excellence focuses on the appropriate use of digital health technologies.

Moe Alsumidaie: With each department pursuing its initiatives, how do they coordinate their efforts and maintain a cohesive approach?

Craig Lipset: Coordination is essential, and the White House Office of Science and Technology Policy (OSTP) is critical in bringing these agencies together. They’ve been mainly focused on pandemic readiness, aligning the efforts of various agencies such as the HHS National Coordinator for Health IT (ONC) and Biomedical Advanced Research and Development Authority (BARDA) with policy changes that support today’s adoption of DCTs and preparing for the future.

Moe Alsumidaie: Considering the investments from BARDA and NIH, what outcomes are they aiming for with DCTs and infrastructures?

Craig Lipset: The investments are strategic; they’re designed to ensure that the infrastructure is ready for future emergencies and beneficial for ongoing research.

Craig Lipset, Co-Founder of DTRA
Craig Lipset Co Founder of DTRA

BARDA, for instance, is considering how to use the infrastructure today — perhaps in pediatric rare disease drug development or vaccine research — so it remains active and doesn’t have to be ‘dusted off’ during a crisis.

Moe Alsumidaie: Training and competencies are vital for researchers, especially at NIH. What competencies are being developed to reflect overall preparedness in deploying DCTs?

Craig Lipset: Training and competencies ensure researchers have the necessary tools and knowledge. While I don’t have specifics on NIH’s current training initiatives, they likely mirror the comprehensive approach seen in the private sector, focusing on ensuring that their researchers have access to the latest DCT tools and technologies. This is crucial for preparedness and efficiency, not just for emergencies but across clinical research.

Moe Alsumidaie: As we look into the future, what do you believe industry professionals and regulators will take away from their explorations into DCT?

Craig Lipset: The industry is at a turning point where DCTs are no longer just a novel concept but a field where we are earnestly evaluating what works. The government seems to be surging ahead with initiatives to create positive pressure for the industry. It’s a symbiotic relationship where each sector can stimulate the other, ensuring continuous progress.

Moe Alsumidaie: Finally, can you touch upon the international landscape of DCTs and how you envision its development?

Craig Lipset: While this year has a strong U.S. focus regarding government insights into DCTs, there’s significant activity in Europe and Asia. We are attentive to the global shifts and advancements in DCTs. It’s important to note how these trends parallel initiatives for pandemic readiness and infrastructure development for domestic research agendas abroad. This is perhaps most evident in the clarifying regulatory positions of regulatory agencies from Europe and Asia on decentralized trials issued through guidance and reflection papers.

In conclusion, Craig Lipset from the DTRA thoroughly examines the role of government agencies in decentralized clinical trials. From the intricacies of agency coordination to the forward-thinking investments in infrastructure, the dialogue elucidates the current state and the promising trajectory of DCTs. As the industry navigates the complexities of economic and regulatory environments, the insights from Craig offer valuable guidance and foresight for the path ahead.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.