The Full Picture: RECIST PLUS

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

Clinical trial representation and how it intersects with patient-centric approaches and inclusive trial designs

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.

PANEL DISCUSSION: How innovation will shape the future of clinical research in oncology

  • 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?

 

How to measurably increase operational efficiency in clinical trials

  • 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

The role of Medical Monitor in ensuring protocol compliance and patient safety in oncology clinical trials

  • 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.

Interactive Speaker-Hosted Roundtable Discussions

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

  1. Roundtable 1: Measuring success by assessing the effectiveness of your patient enrollment strategy
    Hosted by Irene Soto, Clinical Operations Expert
  2. Roundtable 2: Advantages and challenges of conducting multi-regional clinical trials in oncology
    Hosted by Deepa Arora, Director, AJNA Therapeutics
  3. Roundtable 3: Fine-tuning the site-sponsor partnership
    Hosted by Cecilia Tran Muchowski, Senior Director, Site Alliances, Genmab
  4. Roundtable 4: Bringing innovation to clinical trials
    Hosted by Bobby Asem, Associate Director, ClinOps, Bluejay Therapeutics

Ensuring regulatory compliance for expedited drug approvals in oncology in the USA

  • 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