Protocol Design Featured Articles

  1. Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge 5/29/2026
  2. Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors 5/29/2026

    Kivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.

  3. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

  4. Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study 5/15/2026

    Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.

  5. Why Site Engagement Isn't Just A Role Anymore 5/14/2026

    GSK’s Laura O'Donnell says site engagement is no longer just a function or team, it’s an organization-wide capability. In this article, she discusses why the traditional CRA relationship model has broken down, how sponsors are using data and AI to better support sites, and why human connection still matters in an increasingly automated clinical trial environment.

  6. The U.S. Clinical Trial Recruiting Pipeline Report – May 2026 5/12/2026

    This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026. 

  7. 5 Critical Risks With The FDA's Real-Time Trial Monitoring 5/8/2026

    Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.

  8. Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It 5/6/2026

    Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.

  9. A Biomarker Playbook For Building Faster, Smarter Clinical Trials 5/1/2026

    Not every trial needs a biomarker, but every development leader should be assessing whether they can be effectively used to improve trial design, boost enrollment, reduce operational waste, and increase the likelihood that a study will answer the question it was built to answer.

  10. ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity 4/30/2026

    Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.