Decentralized Clinical Trials (DCTs) are revolutionizing clinical research, offering potential improvements in trial efficiency and participant diversity. In a recent discussion, we explored these innovations with Pamela Tenaerts, Chief Scientific Officer at Medable, and Ken Getz, Executive Director and Research Professor at the Tufts Center for the Study of Drug Development. Pamela highlighted the initial research collaboration with Ken, which identified promising trends in DCTs but lacked detailed data, prompting a more granular study. This comprehensive research effort involved a consortium of stakeholders to delve deeper into the specifics of DCTs, aiming to optimize and standardize their implementation.
Moe: What prompted this study on Decentralized Clinical Trials?
Pamela Tenaerts: I’d like to set the stage before diving into the specifics. Our initial research, conducted in collaboration with Ken and the Tufts Center for the Study of Drug Development, focused on the net present value of decentralized clinical trials. This research highlighted some promising timeline improvements, screen failures, and amendments. However, our data was high-level and lacked the detailed granularity to answer many critical questions. For instance, while we could see overall trends, we couldn’t pinpoint specific factors driving these improvements or fully explain why certain outcomes occurred. This gap in our understanding highlighted the need for a more comprehensive study.
To address this, we supported Tufts CSDD on a more detailed data collection effort through a consortium involving various stakeholders, including pharmaceutical companies, biotech firms, and contract research organizations (CROs). By collaborating with these entities, we aimed to gather more granular data on various aspects of Decentralized Clinical Trials, such as specific technologies, population demographics, and study indications. We also worked to establish agreed-upon metrics, which was a significant achievement given the complexities of clinical trials. This consortium approach allowed us to delve deeper into the nuances of Decentralized Clinical Trials and provided a clearer picture of their impact on different study parameters.
Moe: Could you provide specific examples from the case study illustrating the timeline improvement?
Ken: Indeed, over the past year, the PACT consortium of 34 companies has contributed data on 60 clinical trials using DCT elements. Our initial findings indicate that trials deploying at least one DCT element are more likely to meet or beat their planned timelines including study start-up and enrollment. DCT use was associated with some observed delay between when the first site and last site were activated but planned study timelines from study start-up through close-out were longer than actual timelines. We also found that when DCT elements were deployed, a smaller relative percentage of total sites were activated.
And several significant associations were observed between DCT use and other performance measures. For example, as the proportion of remote and virtual visits increased, the number of protocol deviations per participant and the number of substantial amendments per protocol decreased.
Moe Alsumidaie: The FDA recently released guidance on diversity in clinical trials. How have Decentralized Clinical Trials impacted diversity among trial participants?
Pamela: Diversity in clinical trials is crucial to ensure the enrolled patients mirror the intended population. PACT’s emerging data shows a promising trend towards increased diversity with Decentralized Clinical Trials, although it hasn’t yet reached statistical significance. Notably, 20% of the diversity action plans reviewed by the FDA in Project Equity between April ‘22 and ‘23, included decentralized elements. This trend aligns with findings from the PACT consortium, which demonstrated that decentralized clinical trials elements like local or specialty labs and home visits significantly contributed to higher levels of diversity. These strategies enable trials to reach a broader demographic by minimizing geographic and logistical barriers that often prevent diverse populations from participating in traditional clinical trials.
Ken: We’ve also published studies indicating similar trends. Specific Decentralized Clinical Trial elements, such as utilizing local labs and home visits, were strongly associated with greater racial and ethnic diversity among participants. By bringing the trial closer to the patient’s home, these strategies make participation more accessible and reduce barriers related to travel, time, and convenience. This increased accessibility not only encourages a more diverse participant pool but also enhances the overall inclusivity of clinical research, ensuring that the trial results are more representative of the population that will ultimately use the treatments being studied.
Moe: What challenges have sponsors faced in integrating digital tools with existing clinical trial infrastructures?
Ken: Integrating Decentralized Clinical Trials elements introduces significant complexity and customization to clinical trials. This complexity can elevate the burden for sites, as they must adapt to new technologies and processes, and it creates variability in patient options, which can complicate study management. For instance, implementing multiple digital tools, such as eConsent, telemedicine visits, and remote monitoring, requires seamless integration with existing systems, which can be technically challenging and resource-intensive. These factors can lead to inconsistencies in data collection and patient experience, necessitating a robust strategy to manage the additional layers of complexity. Many sponsors joined the consortium to understand these complexities better, aiming to optimize the use of decentralized clinical trials components effectively.
Pamela: On my end, I’m a co-lead on a project with CTTI focusing on trial flexibilities and data quality. Ensuring data quality amidst such flexibility is crucial because flexible approaches, while beneficial for patient engagement, can pose risks to data integrity. For example, when visits are conducted remotely or via different modalities, ensuring that the data collected is consistent and reliable for its intended purpose becomes essential. Our project aims to develop recommendations and research how these flexible approaches impact data quality. By establishing best practices and guidelines, we strive to help sponsors maintain high data integrity standards while leveraging the benefits of Decentralized Clinical Trials. This will ultimately lead to more reliable and efficient clinical trials benefiting researchers and participants.
Moe: How do you ensure the quality and integrity of data collected in remote settings compared to traditional in-person trials?
Pamela: Several elements contribute to maintaining data quality in remote settings. Electronic clinical outcome assessments (eCOA) are well-established and have proven reliable, providing consistent and accurate data whether administered remotely or in person. Additionally, using patients’ devices (BYOD) for data collection often proves more effective than provisioned devices, as patients are more familiar with their technology, leading to fewer technical issues and greater compliance. BYOD may need to be supported with provisioned devices to allow representative participation of those who may not have a device that meets the minimum requirements of the study or who may not have a data plan to support participation. Adhering to quality-by-design principles also plays a crucial role, as these principles emphasize proactive planning and process control, ensuring that data quality is built into the study from the outset.
Ken: We’ve observed significant growth in central and remote monitoring, which is crucial for maintaining data quality in decentralized clinical trials. One fascinating insight from our research is the continued high level of source data review and verification that is conducted, particularly among smaller companies targeting rare diseases. These companies often have a higher risk aversion, leading them to implement rigorous data verification processes. As we refine our execution models, remote and central monitoring will become increasingly vital in ensuring data integrity. This involves leveraging advanced analytics and real-time data monitoring tools to detect anomalies and ensure consistency across various data sources. By integrating these sophisticated monitoring techniques, we can maintain the high standards of data quality required for regulatory compliance and scientific validity, even in the decentralized trial setting.
Moe: What are your final thoughts on the future of Decentralized Clinical Trials and the importance of collecting robust data?
Ken: We’re thrilled that — through the PACT consortium of pharmaceutical and CRO companies — we are compiling a robust, and growing analysis dataset of actual DCT use in clinical trials. This data is crucial for companies considering decentralized clinical trials as it provides a solid foundation for making informed decisions. By demonstrating the tangible benefits and shortcomings of DCTs we can help move the field forward in a thoughtful and fit-for-purpose manner. We aim to encourage more companies to join PACT, as increasing the amount of high-quality data will deepen our understanding and drive broader adoption. The collaborative effort within our consortium exemplifies the importance of shared knowledge and collective progress in revolutionizing clinical trials.
Pamela: I echo Ken’s sentiments. Moving the field forward requires robust data to verify the effectiveness of DCT elements. We’re currently in the crucial phase, ensuring these components deliver on their promises. The ongoing data collection and analysis will provide the insights needed to optimize and standardize trials with Decentralized elements. This effort is essential not only for proving the value proposition for trials with of Decentralized elements but also for refining best practices and ensuring regulatory compliance. Ultimately, our work aims to establish a new standard in clinical trials that is more efficient, inclusive, and adaptable to the diverse needs of participants.
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.
