Protocol Design Featured Articles

  1. Lessons In Pivoting From A Clinical Trial Launch In Uganda 6/3/2026

    Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.

  2. Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community 6/1/2026

    CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access. 

  3. 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.

  4. Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge 5/29/2026
  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.