On Friday, November 15, 2024, the Decentralized Trials & Research Alliance (DTRA) held a fireside chat between Brandon Maggio, GSK’s Global Head of Digital Operations & Process Optimization, and Alison Holland, Medable’s Chief Customer Officer. They were gathered to discuss the evolving landscape of decentralized and digital clinical trials and how best to drive change management in an era of continual changes within trial research. The following blog is a summary of their discussion.
For GSK, increasing accessibility to trial participation has been a company-wide primary objective for years. This objective, alongside changing regulatory guidelines and practices, prompted them to reimagine how clinical research could be conducted with decentralized modalities. Their goal was to make digital and decentralized modalities a repeatable, business-as-usual part of their business to improve patient access and enhance understanding of health outcomes and drug efficiency.
While this occurred, technologies like electronic clinical outcome assessments (eCOAs), electronic informed consent (eConsent), and telehealth were evolving. Decentralized clinical trials (DCTs) had transitioned from a nascent concept during the pre-pandemic and pandemic eras into a foundational element of modern clinical research.
Now, as the industry moves beyond the Gardner Hype Cycle’s “trough of despair” to actual pragmatic implementation, organizations like GSK have demonstrated the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency. Here’s a brief overview of how.
Change management: “It takes a village.”
Change is never easy, especially when it involves transformational shifts in how organizations operate. Resilience is key to navigating transitions. To drive adoption, GSK understood it needed to engage stakeholders across its spectrum, from medical teams to regulatory counterparts.
As mentioned, their primary objective of patient accessibility helped ensure that DCT modalities (such as eCOA, digital measures, etc.) were integrated into GSK’s broader drug development outcomes. This “philosophical alignment” ensured that decentralized modalities were not just tactical solutions but strategic transformation enablers for different stakeholders.
The organization set ambitious but achievable targets, acknowledging that implementation would require iterative refinement. They established dedicated teams within digital operations to maintain compliance and efficiency while developing standardized procedures aligned with regulatory requirements. This structural approach enabled continuous optimization based on disease-specific needs and operational metrics.
The company's use of performance metrics and data-driven insights proved particularly effective in securing senior leadership buy-in. Brandon notes their philosophy was simple:
“What were the things that we wanted to be able to measure together and really see the evidence of that progression?”
- Brandon Maggio, Global Head of Digital Operations & Process Optimization, GSK
Once that was defined, the team sought to educate the organization on their initiative. They recognized the importance of communication and education, making them pillars of their change management strategy.
Access to regulatory information through video resources and direct communications was widespread and available to everyone. This, alongside informal webinars and lunch-and-learns, helped foster a learning culture that aligned teams on objectives, terminology, and practical insights.
Scaling, accountability, and embracing change
For large organizations like GSK, scaling new approaches like DCT adoption requires a robust accountability framework. Clarity around roles and responsibilities at every level ensures all stakeholders understand their contributions to the broader strategy. Regularly revisiting these roles and maintaining alignment on objectives and milestones is essential to staying on track. This approach streamlines decision-making and builds trust and cohesion within the organization, creating a strong foundation for sustainable growth.
Transformational change is inherently risky and often comes with its share of obstacles. Resilient organizations view these challenges as opportunities to learn and evolve. Those organizations that can openly and honestly analyze what went wrong and why can foster a culture of trust and growth and reduce the likelihood of repeated missteps.
The horizon ahead
Scaling DCTs in large organizations is a complex but rewarding endeavor. By focusing on strategic alignment, stakeholder engagement, and continuous learning, companies like GSK are leading the way in creating a more patient-centric and efficient clinical trial ecosystem. The journey requires resilience, transparency, and a commitment to transformational change.
As the DCT landscape evolves, the focus is shifting toward leveraging novel data collection methods to enhance trial efficiency and outcomes. Decentralized modalities open new opportunities for gathering enriched datasets that enable real-time decision-making. These advancements support innovative trial designs, such as basket and master protocols, accelerating the evaluation of health outcomes, drug efficacy, and safety. By embracing these cutting-edge capabilities, organizations can drive faster, more adaptive clinical trials that meet the needs of diverse patient populations.
These efforts ultimately benefit patients, clinical sites, and the broader healthcare industry, paving the way for a future where clinical trials are more accessible, efficient, and effective than ever before.
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