Archives: Agenda

CASE STUDY Pediatric Case Study: Insights for Faster, Safer Clinical Trials

Paediatric trials bring amplified risks, tighter regulations, and higher stakes for patient safety – but the lessons learned extend far beyond children’s studies. In this case study, we examine the unique challenges of conducting a paediatric clinical trial and explore how its insights can be applied to improve planning, safety oversight, and operational efficiency in any therapeutic area.

 

  • Navigating Complex Risk Profiles: Managing safety, dosing, and ethical considerations in vulnerable populations.
  • Pharmacovigilance in Practice: Meeting rigorous monitoring and reporting demands under high scrutiny.
  • Recruitment and Engagement Strategies: Overcoming barriers to participation with patients, caregivers, and advocacy groups.
  • Transferable Takeaways: Applying lessons from paediatric research to accelerate and safeguard trials in all therapeutic areas.

Keynote: Clinical trials in the age of AI – What you’ll discover

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.

 

Trial De-risking: Three Sources of Noise That Quietly Sink Clinical Trials

Every day of Phase III delay costs roughly $56,000, and much of the signal sponsors pay for is lost to three sources of noise that are largely within our control: patient attrition (Phase III dropouts frequently exceed 30%), measurement variance in subjective endpoints (placebo response of 20–40% is the norm in recall-based PROs), and unmeasured environmental exposure (light is still captured, if at all, by a checkbox).

 

This session presents a practical framework for addressing each source with measurement rather than molecules, combining behavioral-science eCOA with sensor-based digital endpoints — ScratchSense for continuous itch and sleep quantification, and RaySense for UV, visible, and infrared exposure. The framework is applicable across dermatology, pruritus-driven indications (atopic dermatitis, CKD-associated pruritus, chronic urticaria, prurigo nodularis), lupus, chronobiology, and photosensitive-drug safety programs. The session includes a live ScratchSense demonstration showing the gap between recall-based itch reporting and continuous objective measurement.

 

Attendees will:

  • Understand how attrition, endpoint variance, and environmental exposure each inflate clinical trial sample size and timelines
  • Learn how behavioral-science eCOA and continuous sensor-based endpoints reduce measurement noise and required sample sizes
  • Examine real-world retention and measurement outcomes, including a recent 28-week dermatology program with 99% retention versus an ~80% benchmark
  • See a live ScratchSense demonstration of continuous scratch capture versus patient-recalled itch

150 Days to Activation: What the UK’s New Trial Start-Up Standard Means for Europe

  • Understanding the UK’s new national start-up target and what it requires from sponsors and sites
  • Ambitious FPI benchmarks: 30 days for rare disease trials and 60 days for other studies
  • How the UK approach compares with clinical trial start-up timelines across European markets
  • What sponsors and sites across Europe can learn from the UK’s drive to accelerate study activation
  • Key enablers for faster start-up globally: streamlined processes, site capacity, and performance management