Protocol Design Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Clinical Failures Persist Because They're Structural, Not Random 4/29/2026

    Clinical failures are no longer contained within a single program but happen across portfolios, companies, and therapeutic areas. Advisor Mikail Evteev suggests the reason is a failure to learn from past mistakes.

  6. Breaking Barriers In Rare Disease Clinical Trials 4/27/2026

    Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.

  7. Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials 4/23/2026

    Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today. 

  8. Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D 4/23/2026

    City of Hope’s Alberto Pugliese, MD, discusses how philanthropic gifts helped launch a landmark multi-center trial to test a combination therapy using repurposed drugs for the treatment of Type 1 Diabetes.

  9. The Patient-Centered Trial Paradigm For Knee Osteoarthritis 4/22/2026

    Although PROs can complicate a trial design, they're essential to reflecting a patient’s true knee OA experience and producing meaningful evidence, explains Katie Mowry, Ph.D., VP of R&D at Organogensis.

  10. A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis 4/21/2026

    A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).