Decentralized clinical trials (DCTs) are revolutionizing the landscape of clinical research. As the FDA navigates this shift, the Decentralized Trials & Research Alliance (DTRA) and the Biotechnology Innovation Organization (BIO) lend their expertise to the FDA by responding to the FDA’s guidance document on Decentralized Clinical Trials. This article delves into their insights.

Embracing Digital Technology in Clinical Trials

DTRA emphasizes the significance of adopting digital technology in clinical trials, particularly integrating digital health technologies (DHTs) and the potential of a ‘Bring Your Own Device’ (BYOD) approach. They reference the pandemic’s digital pivot, showcasing the potential of these tools in clinical research. In an era where telehealth became standard, monitoring patients through wearables and health apps highlighted the vast potential and challenges of DCTs. DTRA also acknowledges the importance of telehealth in clinical trials but urges the FDA to provide clarity on telehealth visits. They stress the need to confirm participant identity at the start of a trial or during the initial remote visit. DTRA raises concerns about the necessity for a physical location linked to trial records. They advocate for more virtual tools and clarity on the roles of local HCPs, especially when they differ from traditional clinical trials unit practices.

BIO emphasizes the importance of pragmatic data collection in the evolving world of decentralized clinical trials. They note that the emerging challenges in clinical trials that incorporate decentralized elements mainly arise from inconsistent data collection methods. This becomes evident when patients use various health tracking applications, leading to disparities in the data. Such inconsistencies can affect clinical research, potentially jeopardizing the validity of results. In a digital age where patients might use anything from a Fitbit to a dedicated medical monitoring device, BIO stresses the need for standardization. Like DTRA, which highlights the COVID-19 pandemic’s impact on digital tools adoption, BIO points out potential pitfalls. They argue that while diverse tools offer patients flexibility, they also introduce variability that can challenge the trial‘s integrity. Furthermore, BIO believes that sponsors remain the guardians of the study’s data quality and integrity, regardless of the trial’s decentralized nature. They advocate for consistent data collection, ensuring that irrespective of the tools used, the data remains accurate.

Oversight by PI, Sponsor, and Service Providers

DTRA discusses the complex nature of oversight in DCTs. They highlight the intricacies associated with the FDA’s Form 1572, especially in decentralized contexts. The modern scenario of a remote patient consulting with a local healthcare professional (HCP) can lead to inconsistencies in data collection and interpretation. DTRA indicates that in the DCT landscape, the PI might not always be involved in selecting or qualifying local HCPs and facilities. They call for clearer documentation in the delegation of authority logs.

BIO, meanwhile, spotlights the crucial role of the trial’s sponsor in ensuring effective oversight in decentralized clinical trials in collaboration with the PI. They highlight that one of the principal challenges in DCTs is ensuring consistent and accurate data collection, especially when patients use a variety of health monitoring tools. As mentioned previously, BIO focuses on the data variability these devices introduce in clinical trial data, potentially affecting the results of randomized controlled trials. BIO advocates for a more defined oversight mechanism; specifically that the sponsor, in conjunction with the PI, must ensure that the trial’s integrity remains uncompromised in the landscape of clinical trials through standardized approaches.

Global Harmonization in Clinical Trials

DTRA stresses the need to align DCTs with global standards. They indicate in their recommendations document that revisions to the ICH E6(R3) are crucial in the interconnected world of clinical research. They believe that as clinical trials cross borders, it’s vital for DCTs to integrate universally accepted practices. DTRA highlights the dynamic nature of today’s global clinical research and suggests that deviations from international standards could introduce complexities. BIO, aligning

with DTRA’s views, amplifies the call for global consistency. They suggest that the foundation of modern clinical research lies in globally harmonized practices. Referring to the ICH E6(R3) Good Clinical Practice Guideline, BIO believes that research’s sanctity and integrity can only be maintained when universally accepted methodologies are adopted. They suggest that clinical trials should adhere to global standards, ensuring consistent and robust practices regardless of the trial’s location.

Summary

The evolution of decentralized clinical trials (DCTs) brings both unprecedented opportunities and intricate challenges. DTRA and BIO provide crucial insights, emphasizing digital technologies, pragmatic data collection, and global harmonization. Their combined expertise highlights the need for a consistent, innovative, and trustworthy approach as DCTs’ future unfolds. As clinical research transforms, collaboration and adaptability will be essential in maximizing DCTs’ potential.

Moe Alsumidaie
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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.