INSIGHTS ON CLINICAL TRIAL DESIGN

• 5 RWE Approaches That Strengthen Precision Oncology

  Real-world evidence is becoming vital in precision oncology. Discover five creative, practical ways sponsors can use RWE to fuel development, sharpen regulatory strategy, and strengthen market access.

• Does 'The Belmont Report' Provide Guidance For Patient Stipends?

  Consider implementing fair and flexible stipend models that account for individual burdens to enhance diversity, equity, and participation in clinical trials.

• Advantages Of Sourcing Biosimilars Vs. Branded Biologics In Clinical Trials

  Evaluate biosimilar alternatives during clinical trial planning to reduce comparator drug costs and improve overall study efficiency without compromising trial integrity.

• From Crisis To Confidence: Ensuring Smooth Regulatory Submissions

  Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

• Bridging The Trust Gap: How Patient Advocacy Groups Transforms Trial Recruitment

  10/27/2025

  Explore how collaboration between researchers and Patient Advocacy Groups (PAGs) can bridge the trust gap that undermines recruitment and can make trial participation more approachable and meaningful.

• RTSM Misalignment Hiding In Your Clinical Trial Protocol

  5/13/2026

  Unclear protocol details can quickly create problems across a clinical trial, but bringing in experienced systems thinkers early to identify gaps before they create downstream issues can help.

• 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.

• Early Phase Clinical Trial Enrollment: How To Avoid Delays From The Start

  1/22/2026

  By operationalizing the early-phase strategies discussed in this article, trial teams can ensure that foundational safety and efficacy data are captured without the delays that derail studies.

• Trends In Clinical Trials In 2025: Navigating A Transformative Landscape

  1/22/2025

  In 2025, it is likely the clinical trial landscape will be shaped by advancements in artificial intelligence (AI), evolving recruitment strategies, and a renewed focus on equitable access.