C-Path Announces New Name and Strategic Direction for its PRO Consortium

Newly renamed Patient-Centered Evidence Consortium expands focus to advance the science and impact of patient-centered evidence in drug development.

TUCSON, Ariz., November 20, 2025 — Critical Path Institute’s® (C-Path) Patient-Reported Outcome Consortium has adopted a new name, the Patient-Centered Evidence Consortium (PCEC), to reflect its broadened scope and strategic direction. PCEC’s new tagline is “Transforming patient-centered outcomes into evidence that drives decisions.”

PCEC’s clear mission is focused on maximizing impact of patient-centered evidence on decision making for drug development, regulatory reviews, therapeutic access, and treatment, through rigorous scientific methods, standards, and multistakeholder collaboration. The new designation signals an evolution from an initial emphasis on regulatory qualification of patient-reported outcome (PRO) measures to a comprehensive approach across clinical outcome assessments (COAs) and the endpoints derived from them. This will ensure that the patient experience is captured through systematic measurement and used to guide decisions across the medical product lifecycle.

“The new name Patient-Centered Evidence Consortium reflects the science and the stakes,” said Sonya Eremenco, M.A., PCEC Executive Director. “Our scientific community has always worked to measure what matters to those with lived experience, ensuring that the evidence we generate is fit-for-purpose, aligned with regulatory expectations, and ready to inform decisions about development, review, access, and care.”

Industry Co-Director Robyn Carson, MPH, from AbbVie, added, “This direction ensures the patient perspective is at the center of healthcare decision making, informing development of reliable and impactful patient-centered endpoints, and driving better outcomes for all stakeholders.”

PCEC will continue all ongoing projects without interruption and will expand work that helps sponsors design and apply fit-for-purpose COAs and patient-centered endpoints. Current efforts include improving how organizations communicate the value of PRO measures to internal stakeholders and establishing member-led working groups to engage regulators and value assessment agencies to advance dialogue and alignment on patient-centered measurement and evidence standards.

“PCEC strengthens C-Path’s patient-focused drug development approach,” said Cheryl D. Coon, Ph.D., Vice President of C-Path’s Clinical Outcome Assessment Program. “By uniting industry, regulators, clinicians, and patients around shared standards, we can deliver evidence of clinical benefit that complements efficacy and safety data and improves decisions across the drug development ecosystem.”

Organizations interested in joining PCEC can contact the Consortium to discuss priorities, membership, and participation in collaborative projects and working groups. More information about the Consortium’s mission, leadership, and membership can be found here.

About Critical Path Institute
Founded in 2005, as a public-private partnership in response to the FDA’s Critical Path Initiative, Critical Path Institute® (C-Path) celebrates its 20th anniversary as a vital, independent, nonprofit. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.

Media Contacts:

Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org

Kissy Black
C-Path
615.310.1894
kblack@c-path.org



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