INSIGHTS ON CLINICAL TRIAL DESIGN

• Keeping Oncology Programs Moving As Complexity Increases

  As oncology trials grow more complex, speed depends on clarity. Consistent oversight and shared data help teams make confident decisions faster without losing control.

• Understanding The FDA's Push For More Representation In Clinical Trials

  Take action to improve diversity in clinical trials by addressing underrepresentation and ensuring equitable access to medical interventions, as emphasized by the FDA’s new 2025 guidance.

• Rewriting Cancer: Advancing Patient Access, Together

  Rewriting Cancer puts a spotlight on the push to connect more patients to clinical trials and how data, technology, and lived experience can help expand access to life-changing care.

• Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM)

  The benefits are clear: CRM accelerates dose finding, reduces patient exposure to unsafe doses, and improves trial efficiency.

• No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure

  1/14/2026

  This use case shows how sponsors can gain clarity on disclosure requirements when entering a new country.

• Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy

  4/11/2025

  Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.

• The Growing Complexity Of Conducting Oncology Trials

  11/17/2025

  As diversity plans and multi-regional considerations become core to trial design, early-phase oncology programs must navigate a landscape that offers unprecedented opportunity.

• Navigating The Complexities Of Cross-Border Clinical Trials

  4/28/2025

  Explore the regulatory, logistical, and patient-centered challenges of cross-border clinical trials, including insights on enhancing collaboration and prioritizing patients in global research.

• ASGCT Symposium: Community-Based Cell & Gene Therapy Delivery

  6/10/2026

  This symposium from ASGCT 2026 explores community-based delivery of cell & gene therapies as a means to improve access, equity, enrollment speed, data quality, and regulatory evidence.