According to the Declaration of Helsinki, in medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language. Often, this document is long and not easy to understand for a participant. In the Netherlands, as of May 2026, a simplified and shortened Patient Information Sheet template has been released. The choices made and first experiences will be shared.

Drawing on survey findings from more than 4,400 clinical trial participants, this session explores how informed consent processes can better support patient understanding and decision-making. Attendees will examine key barriers to ICF comprehension, including document length and confusing terminology, alongside strategies for creating clearer, more patient-friendly consent experiences. The session will also highlight the benefits of eConsent and feature patient advocates sharing firsthand perspectives on how consent processes influence trial participation decisions.

Recruitment performance is a critical determinant of clinical trial timelines, yet current approaches to assessing delays—primarily comparing planned versus actual randomisations—lack a consistent framework to explain why deviations occur. Root cause analysis is often fragmented, as each stage of the process is measured in different units, from country and site activation to screening and randomisation. This paper introduces CSSR, a standardised analytical framework that decomposes recruitment into four key drivers: Clinical Trial Applications (C), site initiations (S1), screening/informed consent (S2), and randomisations (R). CSSR translates the impact of each stage into a common metric—days gained or lost—using defined formulas and algorithms based on planned and actual milestones. By harmonising how recruitment performance is measured and communicated, CSSR enables clearer root cause analysis, improves transparency, and supports more informed decision-making across clinical trial stakeholders.

To manage a multi-year, event-driven mega trial, we built an in-house Clinical Excellence Solution that integrates fragmented clinical, operational, CRO, and real-world data to deliver near-real-time insights and proactive trial management. Powered by an internal data warehouse and AI/ML models, it flags patients at risk of dropout and sites at risk of underperformance, enabling targeted interventions. This session outlines development, scaling, and reusable approaches to reduce burden and improve outcomes.

This presentation outlines Johnson & Johnson’s initiative to digitise Recruitment & Retention planning led by global teams with the goal of improving strategic alignment, execution, and efficiency across local teams. The effort aims to transform existing insights into actionable, scenario-based strategies that can be used consistently at global, country, and site levels. The presentation will outline a complex organisational structure and how technology and change management enable seamless operations and enhance R&D productivity. The session will be set up as an interactive workshop after an overview of how J&J solved its complex challenge of creating coordination across R&D operations.

How do you sustain engagement through multi-year outcome trials as a leading molecule expands into new therapy areas? Novo Nordisk found the answer as semaglutide expanded into other therapy areas: a purpose-built, cross-functional participant engagement model supported by continuous scientific and operational feedback loops, localised engagement tools, and transparent communication. The result was sustained community building, strengthening trust, and maintaining engagement and retention across SELECT, FLOW, and SOUL globally.

This presentation focuses on the FACILITATE sustainability and implementation model as a practical pathway for embedding patient-centric data return into routine clinical research practice. FACILITATE demonstrates that sustainable implementation requires more than policy ambition; it depends on coordinated governance, interoperable technical standards, operational workflows, education, and ecosystem alignment. The project developed five integrated use cases covering patient-friendly data return guidance, interoperable architecture based on FHIR and IPS standards, GDPR-aligned governance frameworks, education and capacity-building resources, and alignment with emerging European initiatives such as the European Health Data Space (EHDS). Central to the approach is a tiered sustainability model combining openly accessible foundational resources with adaptable implementation components tailored to sponsor, site, and technology environments. The talk will explore how this model reduces implementation burden while supporting scalability, regulatory alignment, and participant trust. It will also address key barriers identified during the project, including legal uncertainty, fragmented standards, operational complexity, and limited support for participant understanding of returned data.

Regulatory expectations for population inclusion are converging globally—ICH E6(R3), CTIS, FDA Diversity Action Plans, Health Canada SGBA Plus—yet no harmonised methodology tells protocol teams how to operationalise them. This session introduces population standards, a new category of clinical research infrastructure, and presents the SGMA Population Standards Program: seven open-access documents spanning eligibility governance, DDI decision frameworks, SOGI data collection with CDISC mapping, and population classification architecture. Using cross-therapeutic protocol analysis data and worked examples including long-acting injectable ART, we demonstrate how structured eligibility pathways replace categorical exclusions—and how one methodology satisfies five regulatory jurisdictions simultaneously.

Recruiting diverse populations into clinical trials is a shared goal—but what’s actually moving the needle? This panel brings together industry leaders who are implementing scalable, measurable strategies to advance diversity, equity, and inclusion. Hear what’s working, what’s still a challenge, and what’s coming next. Through real-world examples and candid discussion, walk away with actionable insights that can be applied to your own recruitment and engagement efforts.