Protocol Design Featured Articles

  1. What Can Clinical Researchers Learn From Commercial Product Launches? 10/15/2024

    Part one of this three-part series exploring modern drug development and its impact on clinical trials and new drug launches connects product adoption concepts with much earlier clinical trial activities.

  2. How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper 10/9/2024

    Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably. 

  3. Want To Improve Study Startup? Get More Efficient 10/3/2024

    John McAdory, VP of ClinOPs at CG Oncology, recognizes that today’s clinical trial designs tend to be very complex, which complicates study startup. He says the key to improving this challenge is to find small ways to be more efficient throughout the process.  

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.