GUEST COLUMNISTS

• Aligning AI Use Clinical Trials With FDA And EMA Expectations

  For any trial conducted in the EU/EEA, regulators want to know that AI used across clinical trial planning, conduct, and analysis is transparent, controlled, and fit for purpose. Jessica Cordes explains how even U.S.-based teams must meet EMA expectations.

• Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It

  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.

• Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24

  FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

• A Biomarker Playbook For Building Faster, Smarter Clinical Trials

  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.

• ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity

  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.

• Clinical Failures Persist Because They're Structural, Not Random

  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.

• Human-In-The-Loop In AI Validation And Control: From Principle To Practice

  Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.

• Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

  Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.