Guest Column | May 6, 2024

Meaningful Industry Change Means Balancing Tech And Human Touch

By Oriol Serra, head of product study design and planning, Evinova

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Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction. We stand at a decisive crossroads, poised to embrace collaborative intelligence as the lever to dismantle historical impediments and propel drug development forward. This involves investing in “in the loop” collaborations and magnifying the network effects of shared knowledge and learnings. Combining human expertise with AI's analytical prowess equips us with a formidable toolkit for more incisive decision-making. Intelligent choices, particularly in the initial stages of study design, can wield significant influence over cycle times, costs, study quality, and patient engagement. By committing to adopting strategies that span both program and trial levels, we can adopt a comprehensive view to harness clinical trials’ portfolio synergies. Through these synergies, we can orchestrate an integrated clinical trial ecosystem that is both efficient and adaptable.

As we peel back the layers of historical benchmarking methodologies against databases bolstered by real-world data (RWD), it becomes clear that our incremental improvements in data-driven trial design and planning, though much needed, are simply not enough. The inefficiencies in clinical research are as persistent as they are perplexing, manifesting in study delays, a reduced return on investment in R&D, and onerous burdens across all R&D players and participants. This acknowledgment isn't a concession of defeat but a call to action for a change of direction — a transformation that places equal emphasis on the technological and the humanistic, ensuring that every stakeholder from pharmaceutical companies to clinical research sites and participants sees the tangible benefits of reduced burdens and maximized efficiencies.

The journey to this change of paradigm is marked by a commitment to continuous, transparent dialogue and a dynamic approach to data exchange across sites, patients, and sponsors. A centralized platform-centric model holds promise for simplifying and unifying the clinical trial process, allowing for robust collaboration and a deeper understanding of site capabilities and patient needs — a stark departure from the limitations of traditional databases.

The Future Of Clinical Trials Is Fully Integrated

Imagine a seamless integration of advanced digital tools and rich data sets, enabling sponsors to propose and refine trial designs through a blockchain-powered platform. Hypotheses informed by historical evidence and RWD are continuously optimized through the expertise of clinical trial sites along with valuable insights from their de-identified local and regional registries. Here, patient advocacy groups and associations are not just bystanders but active contributors, offering longitudinal insights that are vital for the holistic development of clinical trials.

As we contemplate such a scenario, it is essential to illustrate how this integrative model could function in practice. Picture pharma company Z, charting the course of a clinical program aimed at evaluating drug candidate ABC for disease X. Envision a digital application suggesting design optimizations based on a synthesis of historical benchmarks, literature, and RWD against the study specifications, design parameters, and constraints. This application could then match the company with countries, sites, investigators, and patient associations/advocacy groups well-suited for their clinical trial. Comprehensive profiles of these entities would be made available, fostering a collaborative environment where initial hypotheses are refined through structured insights. This iterative dialogue with sites and investigators would lead to a refined clinical trial design that's corroborated by site and patient insights plus evidence. The completed protocol, once shared with the contributing participants, becomes the blueprint for an efficient and impactful clinical trial. Clinical research sites confirm their participation and collaborate on recruitment plans that are responsive, flexible, and patient-centric. A finalized study plan emerges, one that is constantly monitored and refined through smart algorithms that not only anticipate risk but assist the operators in prescribing the best next action to optimize operational success, making the equally overly abused and undesirable traditional “rebaselining” exercise a thing of the past.

Meaningful Advances In Tech Require A Human Touch

In this scenario, the application is not merely a tool but a learning entity, evolving with each data point and interaction, reinforcing the recommendations for future trials and stitching together a fabric of information across the clinical trial ecosystem for portfolio optimization.

This paradigm shift transcends mere procedural updates; it necessitates a holistic transformation guided by a rigorous change management framework. To successfully navigate this journey, we must synchronize changes across people, processes, and technology. This means not only adopting new operating models but also empowering our people — preparing them through education, aligning their aspirations with organizational objectives, and fostering a culture open to innovation. Simultaneously, we must streamline processes to be more agile and human-centric, while seamlessly integrating technology that complements and augments human expertise. Abandoning outdated practices is not sufficient; they must be replaced with innovative approaches that are embedded within the fabric of our operations, encouraging collaboration and driving efficiency.

Yet, the path we carve today is not just with innovative technology but with the timeless values of empathy, collaboration, and shared vision. In the quest to reshape the innovation frontiers of clinical research, we have a responsibility to blend these values seamlessly into our operational ethos. Only then can we truly transform the human-centered experience and expedite the delivery of breakthrough therapies for patients in need.

This is not merely a theoretical exercise but a practical imperative. As we forge ahead, the responsibility to ignite this transformative change lies with us — the architects of the future of clinical research. The time for incremental steps has passed; now, we must leap forward with conviction and purpose.

A Clinical Trials Call To Action

Our industry stands at a pivotal juncture — it's time to pivot and pioneer a new innovation frontier. We must collectively strive to overcome the inertia of outdated models and harness the vast opportunities presented by advanced technologies combining the power of in-depth human experience and data-driven insights. We are presented with an unprecedented opportunity to dismantle the barriers to efficient clinical trial design and execution, replacing them with integrated and interoperable human-centric systems that prioritize rapid, equitable access to innovative therapies.

We are faced with the imperative to innovate courageously, to synergize the depth of human expertise with the precision of AI, and to implement digital solutions that enhance our collaborative potential with interoperable workflows and reusable insights.

The path forward is clear: We must be pioneers, collaborators, and innovators. By adopting a unified vision of progress, we can actualize the ambition of delivering therapies to patients more swiftly and effectively, igniting a beacon of hope that extends beyond clinical trials into the broader healthcare spectrum. The time for change is now, and the responsibility to lead is ours.

About The Author:

Oriol is a seasoned leader in clinical development and operations, with over two decades of experience across the life sciences sector. With a background spanning pharma, consulting, strategy, and digital technology, Oriol's expertise is underpinned by formal education in business administration, machine learning, and clinical trials management. As the current head of design and planning at Evinova, part of the AstraZeneca Group, he guides a multidisciplinary product development team in revolutionizing clinical trial design and planning through innovative digital and data-driven solutions. Oriol's strategic approach, integrating ML/AI, has catalyzed innovation in clinical trial optimization, focusing on enhancing patient care and accelerating drug development. His previous roles, including leadership positions at ZS Associates and Veeva Systems, and his impact at Pfizer, highlight his ability to transform clinical operations. Oriol’s educational credentials, including an executive MBA and specialized training in ML, reinforce his role as a visionary in advancing the life sciences field.