Critical Path Institute is a major part of Arizona's growing innovation economy. The pathways to innovation that the Institute opens surely represent an excellent return on our public investment and are just as important to the many people around the world who will benefit from collaborative efforts that lead to new medicines.
-Former Arizona Governor Janet Napolitano
Patient-Reported Outcomes (PRO) Consortium
Critical Path Institute (C-Path), in cooperation with the U.S. Food and Drug Administration (FDA) and the medical products industry, has formed the Patient-Reported Outcomes Consortium for the purpose of developing, evaluating, and qualifying PRO instruments with the FDA for use in clinical trials designed to evaluate the safety and effectiveness of medical products.
Instruments
PRO instruments involve measurement of one or more aspects of a patient's health status based on information gathered directly from the patient, without interpretation by physicians or others. Patients provide information concerning the impact of an intervention or therapy from their perspective. PRO instruments offer a means for capturing how a patient feels or functions with respect to her/his health or condition.
There are many disease areas for which adequate PRO instruments are not available. PRO instrument development is very expensive, resource-intensive, and time consuming due to the extensive research and validation process. Under the direction of Dr. Stephen Joel Coons, the PRO Consortium provides a critical mass of experts with different skill sets, experiences, and new approaches. The PRO Consortium consists of scientists from C-Path, pharmaceutical, biotechnology, device, and diagnostic companies, and from the FDA and National Institutes of Health (NIH).
C-Path's Role
In this Consortium, C-Path's role is to serve as a recognized and respected neutral third party that provides overall administrative support and oversight. C-Path provides a Director who is responsible for the overall management of the Consortium, and establishment of a process for identification, prioritization, and development of potential PRO instruments. The Director and his staff coordinate all projects and provide financial oversight and project implementation management. Working with other Consortium participants, C-Path will develop and publish scientific articles and support educational activities with data, expertise, and other outcomes from the projects supported under the Consortium, to benefit all stakeholders and the public health.
March 23, 2010 - First Annual Patient-Reported Outcomes Consortium Workshop
Current Members
Below is a list of firms that are current members of the PRO Consortium:
- Abbott Labs
- Actelion Pharmaceuticals
- Allergan
- Amgen
- Astellas Pharma
- AstraZeneca Pharmaceuticals LP
- Boehringer-Ingelheim Pharmaceuticals, Inc.
- Bristol-Myers Squibb
- Eisai
- Eli Lilly & Company
- Forest Laboratories
- Genentech/Roche
- GlaxoSmithKline
- Ironwood Pharmaceuticals
- Johnson & Johnson
- Merck Sharp & Dohme
- Novartis Pharmaceutical Corporation
- Novo Nordisk
- Pfizer, Inc.
- sanofi-aventis, US, Inc.
- Sepracor
- Shire
- Takeda Pharmaceutical Company
- UCB
C-Path PRO Consortium Leadership Team:
- Stephen Joel Coons, PhD, Director
- Jason Lundy, PhD, Assistant Director
- Kamalika Datta, Project Manager