Protocol Design Featured Articles

1. Why More Biotechs Are Starting Trials In Australia 8/27/2025

   Why are so many U.S. biotechs heading to Australia for their first-in-human trials? Speed, cost, and simplicity. In our latest piece, Megan Robertson and Tina Soulis break down how sponsors can move from protocol to first patient in just a few months—while saving money and generating data regulators will accept worldwide.

2. J&J Taps Tau-Based Diagnostics To Improve Alzheimer's Disease Trial Design And Enrollment 7/31/2025

   Johnson & Johnson's Fiona Elwood, Ph.D., discusses the potential of tau-based diagnostics to help design better trials and improve patient enrollment in Alzheimer's disease studies.

3. CDISC's New 360i Helps Move Trial Design From Manual To Modern 7/30/2025

   Take a deeper look into the CDISC 360i initiative by discovering 360i's benefits and learning how to get involved in its development and rollout.

4. Age Restrictions In Clinical Trials Unjustly Harm Adults With Childhood Cancer 7/28/2025

   How old is too old for a pediatric cancer trial? Mom-turned-patient advocate Rosemary Sherrod argues that too-stringent age criteria wrongly exclude pediatric cancer patients as they approach adulthood.

5. From Protocol To People: Teva's Patient-First Clinical Trials Approach 7/14/2025

   Teva Pharmaceuticals' Head of Global Early Clinical Development Eran Harary, MD, shares how the company approaches drug development by getting patient input early and often.

6. 2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets 7/3/2025

   Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.

7. Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research 7/2/2025

   CEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.

8. Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial 6/13/2025

   Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.

9. Never Underestimate The Power Of Clinical Operations 5/28/2025

   Too often, clinical operations is treated as a transactional or downstream function, says clinical operations strategist Suzanne Vyvoda. She wants to change how we see and treat ClinOps.

10. Inside The Trials Aiming To Stop Vision Loss For Rare Eye Disease Patients 5/27/2025

    Ocugen Chief Medical Officer Huma Qamar, MD, MPH, CMI, discusses two rare disease trials and how the company's managed their protocol design, PI selection, and patient recruitment.