Protocol Design Featured Articles

1. Navigating The Challenges Of Cell Therapy Clinical Trials 12/5/2025

   IN8bio CEO William Ho shares how they overcame operational challenges unique to cell therapy research, including how to carefully conduct site expansion and onboard new sites without disrupting study timelines.

2. Patient Input Is A Must — Even Under Time And Money Constraints 12/4/2025

   Stacie J. Bell, PhD, chief clinical research officer of Lupus Therapeutics, discusses the positive impacts patient advocacy groups can have on patient recruitment, patient retention, protocol design, and more.

3. Digital Biomarkers Are Reshaping Alzheimer's Patient Experience And Data 11/26/2025

   Cognito CEO Christian Howell shares how EEG and digital biomarkers are reshaping recruitment, patient experience, and the quality of study data in Alzheimer’s research.

4. Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs 11/13/2025

   Cognixion CTO Chris Ullrich introduces the Axon-R Nucleus bio-sensing hub and discusses its feasibility trial, highlighting the importance of patient input, caregiver quality of life, and regulatory support. 

5. Sponsors Collect Too Much "Non-Essential" Data, Say Tufts And TransCelerate 11/6/2025

   A collaboration between Tufts CSDD, Tufts School of Medicine, and TransCelereate BioPharma revealed just how much extra data sponsors are collecting — and why that's a problem.

6. Behavior Modeling Can Help Sponsors Better Understand Sites And Patients 11/4/2025

   Learn how behavioral modeling can identify patients at risk of dropout and sites that may need additional support, so you can build a more resilient research network.

7. Funding Diversity Where It Starts — At The Site 11/3/2025

   After crossing paths with retired family physician and researcher Dr. Bryce Palchick at two conferences, I learned about ACRO’s new Diversity & Inclusion Site Resource Grants Program — an effort funding community sites like Bryce’s to make trial diversity more than a buzzword by supporting real, grassroots engagement.

8. How AI Is Transforming Patient Stratification 10/31/2025

   Discover how AI tools can help stratify or group patients into subtypes that respond differently to treatment.

9. Trends In Rare Disease Trials: Recommendations 10/24/2025

   In the third article of this series, analyst reveal their top 6 recommendations for designing selection criteria and selecting solution options to optimize rare disease research outcomes.

10. FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials 10/23/2025

    As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.