Protocol Design Featured Articles

1. 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.

2. 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.

3. 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.

4. What's The Risk Of Letting Researchers Use LLMs? 5/21/2025

   Who should be using AI and how? Sage Therapeutics' Jake Alme explores AI use in clinical research, examining its use shifting toward more complex applications and discussing the risk of using it in the public domain.

5. Celebrating Clinical Trials Day, Part 2: Trial Optimization In Action 5/20/2025

   Celebrate Clinical Trials Day 2025 with these industry experts as they share experiences and advice related to trial design, regulatory and compliance, and outsourcing challenges.

6. 5 Ways AI Is Changing Clinical Research — And How To Embrace It 5/15/2025

   Discover how AI is transforming clinical trials, learn real tools already in use, and get practical guidance for clinical professionals — especially CRAs and site teams — looking to upskill in an AI-enhanced environment.

7. Overview Of Idiopathic Pulmonary Fibrosis: Global Clinical Trials Landscape 5/14/2025

   Explore the growing number of clinical trials and innovative approaches for Idiopathic Pulmonary Fibrosis (IPF) treatments.

8. How Recursion Is Industrializing Clinical Trials With AI 5/12/2025

   Recursion SVP of Clinical Development and Data Science Sid Jain discusses the company's three-point "ClinTech" strategy, focusing on AI-assisted trial design, trial execution, and evidence generation.

9. Caregiver Distress: The Hidden Burden Of Dementia With Lewy Bodies — And Why Measuring It Matters 5/7/2025

   Taking care of a loved one can be challenging. Cognition Therapeutic experts contend that caregivers’ distress levels must be evaluated to better understand the impact of dementia with Lewy bodies (DLB) on patients, families, and society.

10. How Close Is The First FDA-Approved Full-Spectrum Botanical Drug For Autism? 5/6/2025

    AJNA BioSciences CEO Joel Stanley details his transition from helping to build one of the largest CBD companies to developing what he hopes will become an FDA-approved botanical drug to treat the symptoms of autism.