Archives: Agenda

• 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

• Assessing the value of innovation in oncology trials: sharing best practice on engaging sites with new technology
• Leveraging the latest technologies to enhance patient experience
• Training sites and staff on new systems to maximize the benefits of the latest technology and streamline processes
• Assessing the efficiency and success of pragmatic trials for more patient-centered approaches: do they work for oncology?

• Identify and eliminate operational inefficiencies that cause bottlenecks in clinical trials
• Organize, implement and maintain the coordination between investigators and study teams, sponsors, and other key operational partners to conserve resources and time to accelerate progress in cancer research
• Implement continuous examination and optimization

• Medical Monitors serve as the primary communication bridge between the study team, investigators, and regulatory bodies & play a critical role in ensuring protocol compliance and protecting patient safety in oncology trials.
• Proactive oversight by a Medical Monitor assures trial integrity, regulatory adherence, and overall study success, making them a key pillar in the execution of high-quality clinical research.
• Medical Monitors facilitate discussions on trial updates including emerging safety concerns, and protocol clarifications, ensuring smooth trial execution.
• A Medical Monitor’s expertise in crisis management is crucial in responding to unexpected safety signals or high rates of SAEs, helping to guide decision-making for patient safety and trial continuation.

• Expediting: Fast track, Breakthrough therapy, Accelerated approval, Priority review, RMAT
• Key considerations: Clinical evidence, surrogate endpoints, post-approval requirements
• Major health policy concerns around support for developing new oncology drugs
• Cost, access, regulation, public funding, balancing innovation with long-term care