In this interview, we sit down with Jane Myles and Joe Dustin, leaders in clinical operations and digital transformation at The Decentralized Trials & Research Alliance (DTRA), to discuss the challenges and innovations in trial technology. They explore the complexities of platform consolidation, the role of single sign-on systems, and the potential of the Bring Your Own Technology (BYOT) model, offering insights into the future of clinical trials.
Moe: Sites juggle up to 22 platforms per trial. Why haven’t we seen a push to eliminate this redundancy if sponsors believe in quality by design?
Jane Myles: Five years ago, I imagined we’d consolidate towards singular platforms, but it didn’t happen. Trial teams often struggle with technology consolidation, and procurement processes are complicated by preferred vendors. It’s a multifaceted issue. For instance, integrating into pharma systems is often underestimated, as even after vendor approval, the compliance and quality levels required are daunting. The complexity of these integrations is a significant barrier.
Joe Dustin: I agree. During the 2010s, the pharmaceutical industry moved towards unified platforms, but following the COVID-19 pandemic, it shifted back to a best-of-breed approach due to the emergence of new capabilities. Integrations are becoming easier, but backend infrastructure still poses challenges. Pharma prioritizes what’s best for their data and quality, often resulting in the use of multiple systems. The rise of micro-capabilities and startups has led to a fragmented landscape, where innovation is rapid but integration remains a hurdle. This complexity is a significant barrier to achieving a streamlined approach.
Moe: Single sign-on systems aim to simplify access, yet they remain confusing. Why is that?
Jane Myles: Single sign-on addresses the front-end access point but doesn’t simplify backend technology. It’s challenging for external tech providers to integrate into these environments. While concepts like IQVIA’s workshops are interesting, the ease of integration remains a question. The ACRP’s site members highlighted single sign-on (SSO) as a priority, but with a little more digging they realized SSO only scratches the surface of the underlying complexity. The real issue is that single sign-on doesn’t address the root cause of technological fragmentation.
Joe Dustin: The complexity lies in integrating into pharma’s internal systems and varying security protocols. While platforms like Okta are becoming the standard, the real challenge is creating a marketplace-like integration that allows systems to connect seamlessly, which our industry currently lacks. The lack of a standardized infrastructure for interoperability is a significant barrier, as every study design tends to be bespoke, complicating data exchange. This complexity makes single sign-on a partial solution at best.
Moe: The BYOT model depends on site tech validation. How do we address concerns it creates a two-tier system, favoring tech-savvy sites?
Joe Dustin: Transcelerate and DTRA work to ensure tech-savvy sites aren’t unfairly advantaged. The goal is to create pathways for pharma to accept data from sites with their own infrastructure, ensuring better data quality and faster access without marginalizing less tech-savvy sites. The challenge is to balance innovation with inclusivity, ensuring all sites, regardless of their tech capabilities, can participate effectively. This approach aims to democratize access to technology in clinical trials.
Jane Myles: It’s crucial to ensure that all sites, regardless of their technological capabilities, can participate effectively in clinical trials. This means creating pathways for pharma to accept data from sites with their own infrastructure, ensuring better data quality and faster access without marginalizing less tech-savvy sites. The challenge is to balance innovation with inclusivity, ensuring that all sites, regardless of their tech capabilities, can participate effectively. This approach aims to democratize access to technology in clinical trials.
Moe: How do we balance sponsor oversight and compliance without turning them into control mechanisms that defeat BYOT’s purpose?
Jane Myles: My interpretation is that sponsor oversight hasn’t changed with ICH E6 R3; it offers more flexibility in data collection methods. Sponsors need to be more flexible in their oversight approach, ensuring quality by design without imposing unnecessary control. The key is to focus on the quality and sequence of consent execution rather than micromanaging site processes, which can stifle innovation and efficiency. This approach allows for greater flexibility and innovation in clinical trials.
Joe Dustin: The focus should be on ensuring quality by design without imposing unnecessary control. This means focusing on the quality and sequence of consent execution rather than micromanaging site processes, which can stifle innovation and efficiency. By allowing for greater flexibility and innovation in clinical trials, sponsors can ensure that they are meeting regulatory requirements while also fostering a more collaborative and efficient environment for clinical trials.
Moe: Looking five years ahead, do you foresee more BYOT adoption or a new generation of sponsor-owned tech?
Joe Dustin: By 2030, I anticipate sites will become more autonomous and tech-savvy, with easier and cheaper access to technology. Pharma will need to accept data from various sources, and the integration and interoperability of systems will improve significantly. The trend towards digital optimization at sites is accelerating, and as AI and data infrastructure evolve, the landscape will shift towards more collaborative and flexible models. This will lead to a more efficient and effective clinical trial process.
Jane Myles: The trend towards digital optimization at sites is accelerating, and as AI and data infrastructure evolve, the landscape will shift towards more collaborative and flexible models. This will lead to a more efficient and effective clinical trial process. By 2030, I anticipate that sites will become more autonomous and tech-savvy, with easier and cheaper access to technology. Pharma will need to accept data from various sources, and the integration and interoperability of systems will improve significantly.
Moe: What is stopping sponsors from treating sites as strategic partners rather than just vendors?
Jane Myles: Many sponsors already view sites as strategic partners, especially in specific therapeutic areas. However, the relationship can still have friction due to differing priorities—pharma seeks speed and quality, while sites desire resources and simplicity. The challenge is to align these priorities and foster a collaborative environment where both parties can thrive. This requires open communication and a willingness to work together towards common goals.
Joe Dustin: The challenge is to align these priorities and foster a collaborative environment where both parties can thrive. This requires open communication and a willingness to work together towards common goals. Many sponsors already view sites as strategic partners, especially in specific therapeutic areas. However, the relationship can still have friction due to differing priorities—pharma seeks speed and quality, while sites desire resources and simplicity.
Moe: What is the Horizon 3 moonshot that no one’s talking about yet but should be?
Joe Dustin: Horizon 3 involves exploring systems that overlap with sponsors, like E-reg binders integrating with ETMFs. The industry needs to leverage digital transformations happening outside pharma to enhance interoperability and data exchange. As sites digitize their operations, the potential for seamless integration with sponsor systems grows, paving the way for a more interconnected and efficient clinical trial ecosystem. This will lead to a more efficient and effective clinical trial process.
Jane Myles: Regulatory changes will drive more interoperability and flexibility, with less data required for approval and more reliance on real-world data post-approval. This will reshape risk assessments and data acceptance formats, creating a more dynamic and responsive regulatory environment. As sites digitize their operations, the potential for seamless integration with sponsor systems grows, paving the way for a more interconnected and efficient clinical trial ecosystem.
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.
