Archives: Agenda

The changing global pediatric clinical trials drug development landscape

This session explores how the global pediatric clinical trials landscape is changing, with a focus on the current state of pediatric research, the practical challenges sponsors and investigators face in planning, initiating, and completing pediatric trials, and how the current global pediatric regulatory architecture plays out in practice. Current trends in pediatric trial planning and implementation will also be discussed.

 

Participants will leave with:

  • A snapshot of where pediatric research stands today
  • Practical considerations for managing burden in pediatric trials
  • Best practices and recommendations for navigating pediatric trial challenges

 

Why Patients Walk Away from Clinical Trials and What the Industry Still Gets Wrong

  • Understanding the key factors that influence patients’ decisions to decline or withdraw from oncology clinical trials
  • Exploring what sponsors, sites, and research teams can do to build greater trust, support, and engagement throughout the patient journey
  • Case Study: Insights from Cancer CAREs International’s Next-Generation Trials project on reducing patient burden and creating more patient-centered trial experiences
  • Sharing practical lessons learned and real-world examples of strategies that have improved patient participation, retention, and overall trial experience

ASK THE EXPERTS! Clinical Trials in The Age of AI

Discover how artificial intelligence is transforming clinical research by streamlining processes from protocol design to regulatory submission. This session explores practical AI applications for overcoming recruitment challenges, ensuring ethical implementation, and shaping the future of oncology trials.

  • Overcome Bottlenecks: Learn how AI breaks cycle inefficiencies in trial design and patient screening.
  • Accelerate Recruitment: See how AI-driven models and molecular matching reduce screening time and failures.
  • Implement Ethically: Understand frameworks for bias mitigation, data privacy, and regulatory compliance.
  • Future Trends: Explore next-decade innovations like digital twins and foundation models.

Outcome: A candid, solution-focused discussion designed to help teams move faster and smarter.

 

PANEL DISCUSSION Maximizing Site Productivity: Reducing Burden and Strengthening Output

  • Addressing site burden during study start-up, recognising that sponsors often assume infrastructure and systems are already in place, when the reality can vary significantly between sites.
  • Exploring how increasing protocol complexity is driving operational challenges and requiring sites to develop more creative and adaptable approaches to trial execution.
  • Strengthening collaboration between sites, sponsors, and CROs to improve communication, efficiency, and study delivery.
  • Creating an environment of trust where sites feel comfortable raising concerns around timelines, resources, and operational complexities without fear of losing future opportunities.
  • Identifying practical strategies to reduce administrative burden while maintaining quality, compliance, and patient-focused outcomes.

New Benchmarks on Clinical Trial Sourcing Models and their Association with Trial Performance

During the past four decades, reliance and use of contract research service providers for drug development capacity and expertise have increased dramatically.  During this period, sourcing models have evolved due to rising protocol scientific and executional demands and company-specific outsourcing strategies and preferences. Despite the long-time horizon and extensive collaboration with CRO partners, until now virtually no research has assessed the impact of various sourcing models on drug development program and clinical trial performance, cost and quality.

In 2026, the Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a robust study in collaboration with 13 pharmaceutical companies to gather empirical evidence characterizing outsourcing strategies and practices and their relationship with drug development performance, quality and cost.  This session presents the results of this research and offers insights into optimizing drug development performance, cost and quality through more effective, fit-for-purpose use of sourcing models.  This study also examined the relationship between sponsor choice of sourcing model and clinical trial performance; functions and capabilities typically outsourced, and clinical trial performance and number of vendors engaged.

 

One Study, Many Partners: Building an Operating Model That Works Across CROs, Vendors, and Regions

Drawing on practical CRO-side experience working within collaborative, multi-partner study models, this session will explore:

  • How biotech sponsors can build an effective operating model when multiple CROs, specialized vendors, and regional partners are involved in the same study
  • Practical case studies showing where multi-partner trials can break down — particularly around decision ownership, cross-partner interfaces, and the addition of new regions or capabilities
  • How focused visibility, clear ownership, and active coordination can help multiple partners work as one study team without increasing the burden on lean sponsor organizations

CLOSING KEYNOTE: SPOTLIGHT ON THE FDA – From FDA Priorities to Patient Access: Building a More Agile Clinical Development Model

  • Examine why faster, more inclusive clinical development matters: helping patients access trials and medicines sooner while enabling the system to evaluate more potential therapies.
  • Discuss public FDA priorities, pilots, and opportunities for constructive stakeholder input that may shape the next phase of clinical development.
  • Translate those signals into practical considerations for trial design and delivery, including feasibility, participant representation, site burden, evidence quality, and data reliability.