Note to File Live - Brett Kleger, Datacubed Health

This episode of the "Note to File Live" podcast features a discussion with Brett Kleger, CEO of Datacubed Health, focusing on the realities, challenges, and marketing misinformation surrounding Decentralized Clinical Trials (DCTs), particularly concerning eCOA (Electronic Clinical Outcome Assessment) and ePRO (Electronic Patient-Reported Outcome) technologies. The core objective of the conversation is to cut through industry jargon and re-center the discussion on the fundamental 'why' behind DCT adoption: providing options for patients and sites, and safely collecting reliable endpoint data. The speakers, including host Brad Fox, express frustration with the ill-defined and often over-marketed nature of the term "DCT," which has led to confusion and sometimes unrealistic expectations across the clinical research ecosystem.

The conversation establishes that the impetus for DCT adoption was twofold: first, the desire to improve the patient experience by offering convenient options (e.g., tele-visits, remote data collection) regardless of location or socioeconomic status; and second, the necessity of safely collecting trial endpoints. The speakers trace the history of DCTs from early, unsuccessful "virtual trials" (circa 2006-2008) to the mass forced adoption during the COVID-19 pandemic, which normalized the use of decentralized components. A key realization post-COVID was that trials do not need to be fully decentralized; rather, they can incorporate components—a concept the guest hopes will eventually replace the term "DCT" entirely, making it simply "various options" for conducting a study. A major point of friction discussed is the role of the site, with the consensus being that the site (specifically the Principal Investigator, or PI) must retain the final choice and liability regarding the utilization of DCT components, even if the technology is provided by the sponsor.

A significant portion of the analysis centers on the problem of industry nomenclature and marketing jargon. Terms like "DCT," "patient centricity," and "AI" are often used loosely, driven by investor interest or strategic initiatives, rather than precise definitions. This imprecision creates friction, especially when dealing with regulated activities. The speakers highlight the critical issue of liability: if a third-party DCT vendor commits "malpractice" (e.g., data collection error), the site is ultimately responsible for filing the deviation with the IRB, managing the audit, and bearing the legal burden. This contractual and regulatory reality underscores why sites need optionality and a strong voice in vendor selection. The guest suggests that vendors should focus less on buzzwords and more on marketing "optionality"—providing safe, compliant choices for patients and sites that minimize burden and integrate seamlessly, ideally working so well that the site staff barely notices their presence. The ultimate goal for technology vendors should be to remove burden, not add another complex system to the site’s already heavy workload.

Key Takeaways: • Re-focus on the 'Why' of DCTs: The primary drivers for decentralized components are enhancing patient optionality (making trials accessible regardless of location or circumstance) and ensuring the safe, compliant collection of primary endpoint data. Technology providers must not lose sight of these core objectives. • Optionality Over Standardization: While standardization is important for data integrity, sites need optionality in choosing technology solutions (e.g., eConsent, tele-medicine platforms) that integrate with their existing workflows and Sops, rather than being forced to adopt sponsor-mandated tools that increase burden. • The Site Bears the Liability: Despite sponsors procuring DCT technology, the site (PI) remains legally liable for deviations, IRB filings, and audit responses resulting from vendor errors or technology failures. This regulatory reality necessitates that sites have the final say on which components are utilized. • Marketing Jargon Creates Friction: Overuse of imprecise buzzwords (DCT, AI, patient centricity) driven by investor or corporate strategy confuses the industry and obscures the practical application of the technology. Vendors should market solutions based on tangible benefits like reduced burden and safe optionality. • The PI Retains Final Discretion: Although the sponsor defines the protocol (which must allow for DCT-capable visits), the discretion to utilize those decentralized components (e.g., tele-visits, specific eCOA devices) rests with the Principal Investigator (PI) at the site level. • Vendor Engagement with Sites is Crucial: Technology vendors should actively seek feedback from site staff (the end-users) outside of specific trials. This engagement should be framed as a community relationship, not a transactional extraction of ideas, to ensure solutions genuinely reduce site burden. • Avoid Adding Site Burden: A critical pitfall for DCT providers is reducing patient burden only to increase site burden (e.g., complex training, multiple logins). The ideal technology is one that is so seamless and reliable that the site staff barely notices it's there. • Future of Site Selection: As site networks mature and adopt ISO compliance and rigorous vendor approval systems, sponsors may increasingly select sites based on their proven technology stacks and Sops, forcing sponsors to adapt protocols to the site environment rather than the reverse. • Data Standardization is Key to Optionality: For sites to choose their own eCOA/ePRO vendors, the industry must achieve robust data standards, ensuring that data collected via different systems can be reported back to the sponsor in a uniform, compliant format.

Key Concepts:

• Decentralized Clinical Trials (DCTs): The use of technology and processes to conduct trial activities outside of traditional site settings, ranging from fully virtual to hybrid models.
• eCOA/ePRO: Electronic Clinical Outcome Assessment and Electronic Patient-Reported Outcome. Digital systems used to collect patient data and clinical outcomes directly from patients or clinicians, often via mobile devices.
• Optionality: The concept that patients and sites should be offered choices in how they participate in or manage a trial, allowing for flexibility and improved convenience, rather than being forced into a single methodology.
• Site Liability: The legal and regulatory responsibility held by the clinical trial site and the Principal Investigator for the conduct of the trial, including data integrity and managing deviations, even when using third-party vendor technology.