Archives: Agenda

• Research and development initiatives have long acknowledged that patient participation in clinical research is driven by “hope for a cure” as a key incentive
• Patient reported outcomes, subgroup analyses, “exit” interviews at study conclusions, help contextualize the value of trial data within a scientific, clinical, and humanistic framework
• Within oncology indications particularly, selective patient targeting, innovative trial designs to accelerate approval, and assessments that reflect how patients “feel, function or survive” are highlighted as distinguishing characteristics.

• The Patient Selection Problem: Current biomarker-based strategies identify <30% of likely responders, leading to high failure rates and inefficient trial designs.
• The SAGE Oncotest Advantage: A best-in-class ex vivo functional profiling platform that tests patient-derived tumor cells directly against the investigational drug to identify true responders.
• Smarter Trial Design: Incorporating functional profiling to enrich responders into the study, thereby reducing required sample size while increasing clinical trial success rates

• The evolving ecosystem of cancer research: adapting trial design amid political and economic shifts
• Strategies for advancing patient-centric trials in 2025, focusing on innovative approaches to enhance trial design and execution
• Streamlining and improving patient involvement, communication, and the simplification of processes in trials to minimize patient burden
• Sharing best practices to foster an engaged patient journey, ensuring patient retention throughout the trial process
• Translating technology to tangible outcomes: What are the latest innovative technologies helping patients throughout the trial

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our prize draw and be in for a chance of winning Apple products or Amazon vouchers. Return your card by 3:15pm on May 15th. The draw will take place at 3:20pm on May 15th in the Exhibition Hall. Make sure you don’t miss out!

• GenAI-Driven Protocol & Enrollment Predictions: Explore how PSI integrates GenAI for protocol similarity searches and enrollment rate predictions, improving accuracy and efficiency in clinical trial planning.
• Expanded Data for Global Feasibility Insights: Learn how VISIONAL™ incorporates three new data sources to enhance site performance analysis and offer insights across 56 countries, supporting better decision-making.
• Faster Trial Planning & Budgeting: Discover how VISIONAL™ enables sponsors to quickly generate multi-country feasibility scenarios and budgets in under 30 minutes, streamlining the planning process.

The need for broad representation: The importance of ensuring that clinical trials include a wide range of patient populations to improve the applicability and validity of results across all demographic groups. This approach helps reflect real-world conditions and ensures treatments are safe and effective for everyone.

Patient-centric trial design: Focusing on designing trials with a patient-first approach, considering their needs, preferences, and challenges to improve engagement and outcomes

Inclusive trial design: Exploring strategies for creating accessible trials, such as flexible locations, culturally sensitive recruitment, and remote monitoring, to ensure participation from diverse groups.

Intersectionality and health outcomes: Examining how diversity, patient-centric approaches, and inclusive design intersect to improve trial relevance, reduce healthcare disparities, and enhance the generalizability of results.

Dr Shamsi will explore the evolution of oncology imaging, the limitations of RECIST 1.1, and how additional measurements can enhance early-phase decision-making and late-phase efficacy confirmation in clinical trials.

• The evolution of oncology clinical trials since RECIST 1.1
• The impact of immunotherapies, cell therapies, cancer vaccines, and ADCs
• RECIST Plus – enhanced features that integrate volumetric and radiological parameters for a more comprehensive analysis

• Fine-tuning the partnership and incentivizing CROs to be more thoughtful in proposals
• Reconsidering PM involvement and responsibilities
• Encouraging data system investment
• Building better budgets on the known