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 Outcome (PRO) Consortium
Critical Path Institute (C-Path), in cooperation with the U.S. Food and Drug Administration (FDA) and the medical products industry, formed the Patient-Reported Outcome (PRO) 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 efficacy of medical products.
Patient-Reported Outcome 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, condition, or disease.
There are many disease areas for which adequate PRO instruments are not available. PRO instrument development is expensive, resource-intensive, and time consuming due to the extensive research and testing process. Under the direction of Stephen Joel Coons, PhD, the PRO Consortium provides a critical mass of experts with different skill sets, experiences, and perspectives. The PRO Consortium consists of scientists from C-Path, pharmaceutical, biotechnology, device, and diagnostic companies, FDA and National Institutes of Health (NIH).
C-Path's Role
In the PRO 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.
April 4, 2012 - Third Annual Patient-Reported Outcome Consortium Workshop
March 15, 2011 - Second Annual Patient-Reported Outcome Consortium Workshop
March 23, 2010 - First Annual Patient-Reported Outcome Consortium Workshop
Current Working Groups
- Asthma
- Cognition (mild cognitive impairment)
- Depression
- Functional Dyspepsia
- Irritable Bowel Syndrome
- Non-Small Cell Lung Cancer
- Rheumatoid Arthritis
Current Members
- Abbott Laboratories
- Actelion Pharmaceuticals Ltd.
- Amgen Inc.
- Astellas Pharma US, Inc.
- AstraZeneca Pharmaceuticals
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Bristol-Myers Squibb Company
- Daiichi Sankyo, Inc.
- Eisai
- Eli Lilly & Company
- Forest Research Institute
- GlaxoSmithKline
- Ironwood Pharmaceuticals, Inc.
- Janssen Pharmaceutical Companies of Johnson & Johnson
- Merck Sharp & Dohme
- Novartis Pharmaceutical Corporation
- Novo Nordisk, Inc.
- Pfizer, Inc.
- Roche
- Sanofi
- Shire Corp.
- Sunovion Pharmaceuticals Inc.
- Takeda Pharmaceuticals US
- UCB Pharma Ltd.
C-Path PRO Consortium Leadership Team
- Stephen Joel Coons, PhD, Executive Director
- Jason Lundy, PhD, Assistant Director