Julie Ross

Julie Ross is CEO of StuffThatWorks, a patient-reported real-world data platform spanning chronic conditions. The author's company affiliation is disclosed in the interest of transparency; this article is intended as an analysis of the regulatory landscape.

Articles by Julie Ross

This article summarizes the FDA's four-part Patient-Focused Drug Development (PFDD) guidance series, the parallel mechanisms emerging in the European Union and the United Kingdom, the operational gaps sponsors most often encounter, and the areas in which large-scale, structured, patient-reported real-world data can and cannot contribute to a PFDD-aligned research plan. Credit: Stock.Adobe.com/Bordinthorn.

Operationalizing the Patient Voice: Converging U.S., EU, and UK Requirements and the Role of Real-World Patient-Reported Data

ByJulie Ross

September 16th 2026

Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.

Julie Ross

Articles by Julie Ross

Operationalizing the Patient Voice: Converging U.S., EU, and UK Requirements and the Role of Real-World Patient-Reported Data

Latest Updated Articles

Trending on Applied Clinical Trials Online

The Evolution of Preclinical CRO Strategic Partnerships: From Transactional Services to Value-Driven Ecosystems in 2026

The Execution Gap: Why Clinical Trial Infrastructure Has to Be Built Before AI Can Deliver

ACT Brief: Epilepsy Trial Feasibility and Family Realities, CRO Partnerships and Strategic Value, and Cortisol and GLP-1 Response

What the Epilepsy Community Has Taught Us About Trial Feasibility

How Clinical Teams Can Build Real Trust With Patient Advocacy Organizations