The FDA's recent release of draft guidance on decentralized clinical trials (DCTs) has sparked both enthusiasm and a call for greater clarity within the pharmaceutical industry. While stakeholders acknowledge the guidance as a crucial step forward, concerns persist regarding Principal Investigator (PI) oversight, data collection scalability, and the integration of emerging technologies.
PI Oversight and the Role of Local HCPs
A significant point of discussion revolves around the use of local healthcare providers (HCPs) in DCTs. The FDA stipulates that while certain trial-related activities can be conducted by HCPs near the participant's home, these providers are not considered trial personnel and may lack comprehensive knowledge of the protocol or investigational product. This raises questions about the PI's oversight responsibilities, particularly concerning data collection and personnel management.
According to Dr. Mark Goldberg, CEO at Allucent, the industry is likely to provide substantial feedback on the PI oversight and the utilization of HCPs. The core concern is how a PI can effectively oversee individuals they have not directly evaluated or hired.
Data Collection and Scalability Challenges
Another challenge lies in the scalability of data collection within DCTs. Norma Rodriguez, Vice President at Saama Technologies, points out that while the guidance presents opportunities for growth in DCTs, the increased data collection demands may pose difficulties for those tasked with these responsibilities. Darcy Forman, Chief Delivery Officer at Science 37, highlights the operational hurdles of gathering extensive data, such as home addresses, from thousands of patients in virtual trials.
Dr. Goldberg also notes that many existing systems may not be adequately designed to capture the specific information required by the FDA, potentially creating technological bottlenecks.
Terminology and Technology Integration
The lack of a unified understanding of DCT terminology remains an ongoing issue. While the FDA's definition aligns with other regulatory bodies like the EMA and ICH, some industry members question whether "decentralized" accurately describes trials incorporating digital technology. There are suggestions to shift the focus from "decentralized clinical trials" to "decentralized elements of clinical trials" to promote inclusivity.
Furthermore, the guidance's limited focus on medical devices and the absence of discussions on artificial intelligence (AI) integration have been noted as missed opportunities. Rodriguez suggests that incorporating AI considerations could better prepare DCTs for future advancements.
The Path Forward for DCTs
Despite these concerns, stakeholders remain optimistic about the future of DCTs. Pamela Tenaerts, Chief Scientific Officer at Medable, emphasizes that the FDA takes all feedback seriously and encourages continued engagement during the comment period. The industry anticipates that the final guidance will solidify decentralization as a standard practice in clinical trials, driving improvements in data quality, diversity, and real-world data collection.
As Forman concludes, the ultimate goal is to integrate DCT principles into the fundamental DNA of clinical trial execution, moving beyond viewing them as merely innovative approaches.
