Protocol Design Featured Articles

  1. DPHARM 2024 Highlights ClinOps Innovations That Address Cost, Complexity, & Capabilities 10/1/2024

    The 14th annual DPHARM conference included sessions ranging from the ROI of DCTs to how and where to innovate in a resource-constrained environment. In this article, we give some of the highlights from this informative annual event.

  2. Why Diversity Of Geography Matters: A Call To Drive Rural Patient Enrollment 9/30/2024

    To make clinical trials more inclusive, CROs and sponsors must intentionally expand to different — including rural — communities to recruit more diverse patients.

  3. Research, Manufacturing, Regulatory, And More: What Are The Challenges With CGTs? 9/27/2024

    UCB Head of U.S. Research Roger Palframan discusses the challenges with CGTs — from complex manufacturing to the need for greater and more meaningful patient engagement to evolving regulations and reimbursement.

  4. Why Sponsors And Sites Must Prioritize Coverage Analysis In Clinical Trials 9/26/2024

    Huron Consulting Group's Casey Charlton explains why conducting a coverage analysis (CA) is a crucial step in the pre-award workflow for sites participating in clinical trials.

  5. Why Industry Must Design Alzheimer's Trials To Include People With Down Syndrome 9/24/2024

    The recruitment and enrollment of people with Down syndrome involve special challenges, but these challenges can be addressed with proper planning and education.

  6. FDA Finalizes Guidance On Dose Optimization For Oncology Therapies 9/16/2024

    The FDA recently finalized its guidance on "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" — with a few notable updates since its draft.

  7. Why Are We Still Excluding Persons With Disabilities (PWDs) In Clinical Trials? 9/13/2024

    Canary Advisors Cofounder and COO Richie Kahn details the National Council on Disability's call for the inclusion of people with disabilities in clinical trials.

  8. Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval 9/11/2024

    Thoracic medical oncologist Sally Lau, MD Lau discusses her role as a principal investigator, from the benefits of the FDA’s accelerated approval pathway to best practices for retaining a challenging patient population.

  9. Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research? 9/6/2024

    ISPOR CEO Rob Abbott discusses Health Economics and Outcomes Research (HEOR) trends and how they're impacting clinical trials. 

  10. More Diverse Enrollment Means More Attention To I/E Language 9/4/2024

    Clinical research nurse Teri Crumb, MSN, RN, CCRC picks out a few potentially problematic inclusion/exclusion (I/E) criteria and details ways to address them.