Patient-Centered Evidence Consortium (PCEC) FAQs

The decision to rebrand reflects how the Consortium’s scope and influence have evolved since its founding. While the original name accurately described the early focus on patient-reported outcome (PRO) measures, our work has broadened to include other clinical outcome assessments (COAs) to derive patient-centered endpoints that generate meaningful evidence for drug development and decision making. The new name better captures this expanded scientific and strategic focus, ensures alignment with C-Path’s leadership in patient-focused drug development, and positions the Consortium for continued relevance and growth as methods and technologies advance.

The new name, Patient-Centered Evidence Consortium (PCEC), captures both the purpose and impact of our work. It conveys that patient-centered outcomes, clinical outcome assessments (COAs), and the endpoints derived from them are central to generating evidence that informs key decisions in drug development, regulatory review, access, and treatment. The term “evidence” underscores the scientific foundation of what we do—turning patient input and experience into measurable, decision-relevant data—while “consortium” reflects our collaborative, multi-stakeholder approach that unites industry, regulators, clinicians, and patients around shared scientific standards.

The rebranding reflects an evolution—not a departure—from the Consortium’s original mission. Our focus has expanded from qualification of clinical outcome assessments (COAs) to advancing a broader framework of patient-centered evidence that includes all types of COAs and the endpoints derived from them. This evolution strengthens our ability to address emerging needs in drug development, including the integration of digital health technologies to support COA-based endpoints, and to generate evidence that informs decisions across the product lifecycle. Strategically, it positions the Consortium to have greater scientific and regulatory impact while maintaining its core commitment to rigorous methods, transparency, and multi-stakeholder collaboration.

Patient-centered evidence refers to scientifically derived information about how patients feel, function, and survive, obtained through fit-for-purpose clinical outcome assessments (COAs) and the endpoints derived from them. It captures the patient’s experience through rigorous measurement—rather than anecdotal input—to demonstrate clinical benefit and inform decisions across the medical product lifecycle. This type of evidence complements other clinical trial data sources, such as biomarkers, by ensuring that what matters most to patients is quantified, validated, and applied to guide regulatory, access, and treatment decisions.

This evolution strengthens how the Consortium delivers value across the drug development ecosystem. For patients, it ensures that their experiences and priorities are reflected in the evidence used to evaluate new treatments. For industry partners, it provides scientifically rigorous, consensus-based methods to develop fit-for-purpose COAs and patient-centered endpoints that can withstand regulatory and value assessment scrutiny. For regulators and decision makers, it delivers credible, standardized evidence of clinical benefit that complements traditional efficacy and safety data. Together, these benefits enhance the quality, relevance, and impact of patient-centered evidence in shaping better treatments and more informed healthcare decisions.

Yes. All current projects and focus areas will continue under the new name without interruption. The rebranding does not change the scientific priorities, partnerships, or deliverables that are already in progress. Instead, it provides a broader and more accurate framework for describing our collective work. The Patient-Centered Evidence Consortium (PCEC) will continue advancing qualification and application of fit-for-purpose clinical outcome assessments (COAs), patient-centered endpoints, and related measurement science to generate evidence that supports regulatory and access decisions.

The transition to the Patient-Centered Evidence Consortium (PCEC) directly supports C-Path’s strategic vision to advance patient-focused drug development across therapeutic areas and evidence types. C-Path’s collaborative model brings together regulators, industry, patients, and academic experts to deliver data-driven solutions that improve how treatments are developed and evaluated. By expanding the Consortium’s scope from patient-reported outcomes to patient-centered evidence, we are strengthening this mission—ensuring that the patient voice is translated into scientifically rigorous, regulatory-grade data that drives decisions. This alignment reinforces C-Path’s leadership in shaping global standards for patient-centered measurement science and evidence generation.

The Consortium’s expanded scope creates new opportunities for members to shape and advance the application of patient-centered evidence across drug development and decision making. Building on our established expertise, we have launched a project on communicating the value of patient-reported outcome (PRO) measures to internal stakeholders, helping sponsors strengthen how COA data are used in development and access evidence generation strategies. We are also preparing to establish member-led working groups focused on engagement with regulatory and value assessment agencies to advance dialogue and alignment on patient-centered measurement and evidence standards. These initiatives will provide members with new avenues to collaborate, share insights, and contribute to shaping global understanding of patient-centered evidence.

Membership in the Patient-Centered Evidence Consortium (PCEC) offers organizations a unique opportunity to shape the science and application of patient-centered evidence across drug development. Members participate in a collaborative network of industry colleagues working together to advance COA and endpoint science. Participation provides early insight into emerging methodologies and regulatory expectations, opportunities to contribute to cross-industry standards, and direct involvement in projects and working groups that influence how patient-centered evidence is generated and applied. Ultimately, membership helps organizations strengthen the scientific credibility and impact of their patient-centered strategies.

Pharmaceutical, biotech, and medical device companies interested in joining the Patient-Centered Evidence Consortium (PCEC) are invited to contact the PCEC Executive Director to express interest and learn more about membership opportunities. The Consortium welcomes organizations that share a commitment to advancing patient-centered measurement science and evidence generation. Prospective members will have an opportunity to discuss their priorities and explore how participation can help strengthen their approaches to COA and endpoint development. Membership is established through a formal agreement with C-Path and includes an annual fee that supports consortium operations and collaborative research activities. Once membership is confirmed, organizations designate representatives to participate in working groups, project teams, and member meetings that drive the Consortium’s scientific agenda. If you’re interested in becoming a member, please contact us at coapadmin@c-path.org.

Existing members will continue to be fully supported throughout the transition to the Patient-Centered Evidence Consortium (PCEC). All current projects, collaborations, and member activities will continue without interruption, and staff will provide clear communication and guidance at each stage of the rebranding process. Members will have access to updated materials, templates, and messaging to reflect the new Consortium name, and opportunities will be available to provide input on how best to communicate this transition within their organizations. Our goal is to make the transition seamless, transparent, and beneficial for all members as we move forward together under the new PCEC identity.