Archives: Agenda

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

PANEL DISCUSSION: Future of Clinical Trial Professionals: How Technology Is Transforming Workforce Roles and Expectations

  • Reimagining responsibilities across clinical trial functions in an AI- and automation-driven environment
  • Evolving from task-based roles to strategic, insight-driven contributors across operations and data functions
  • Redefining entry-level roles as technology reshapes foundational skills, expectations, and career pathways
  • Identifying the new capabilities required to ensure technology enhances, not replaces the expertise of clinical trial professionals

How Real-World Data Drives Enrollment of Undiagnosed Patient Populations

Leveraging peer-reviewed science to bridge the gaps in diagnoses to connect more patients with clinical trials

  • We show how Patient and Site Burden Indexing helps quantify barriers to clinical trial participation, setting the foundation for smarter recruitment strategies
  • How to go beyond the traditional site feasibility by combining real-world data from patient feasibility studies and patient population insights to identify and reach more patients
  • Real-life case studies from our peer-reviewed papers demonstrating how data-driven, tailored campaigns highlight diagnosis gaps, improve patient reach, and de-risk enrollment outcomes