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The Patient-Reported Outcome (PRO) Consortium was formed in late 2008 by the Critical Path Institute (C-Path) in cooperation with the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research and the pharmaceutical industry, and formally launched in March 2009. The mission of the PRO Consortium is to establish and maintain a collaborative framework with appropriate stakeholders for the qualification of PRO measures and other clinical outcome assessment (COA) tools that will be publicly available for use in clinical trials where COA-based endpoints are used to support product labeling claims. The PRO Consortium’s membership is comprised of pharmaceutical companies along with C-Path as the managing member. Patients, clinicians, measurement consultants, and representatives from the FDA and National Institutes of Health (NIH) provide critical advice and assistance to the PRO Consortium’s Coordinating Committee and working groups. Patient-Reported Outcome Measures and Other COA Tools

PRO measures assess one or more aspects of a patient’s health status based on information gathered directly from the patient, without interpretation by clinicians or others. Patients provide information concerning the impact of an intervention from their perspective. PRO measures offer a means for capturing treatment benefit in terms of how a patient feels or functions as a result of a therapeutic intervention.

There are many disease areas for which adequate PRO measures are not available. PRO measure development can be 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 including scientists from C-Path, pharmaceutical/biotechnology companies, FDA, and NIH.

Other COA tools include clinician-reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures. These tools are used in diseases or conditions where patient self-report is not possible or not sufficient, or where other assessments may measure the concept of interest more accurately. The PRO Consortium working groups consider all COA tools when determining the best choice of assessment type for a given context of use and are working toward the qualification of other COA tools where appropriate. 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 an Executive Director who is responsible for the overall management of the Consortium and establishment of a process for identification, prioritization, and development of potential COA measures. The Executive Director and his staff coordinate all projects and provide financial oversight and project implementation management. Working with other Consortium participants, C-Path coordinates the development and publication of scientific articles and supports educational activities with data, expertise, and other outcomes from the projects supported under the Consortium, to benefit all stakeholders and public health more broadly.

There is an acute need for therapeutic interventions that can slow or halt the progression of Alzheimer’s disease (AD), and it is currently believed that intervention is necessary at a very early stage of the disease. Assessment of the impact of subtle cognitive changes in early AD on a patient’s ability to perform the daily activities necessary to remain independent may be a critical tool for measuring effects of potential therapeutic agents being tested in clinical trials. The Cognition Working Group is gathering evidence to support the University of California San Diego Performance-based Skills Assessment (UPSA) as a performance outcome (PerfO) measure for assessing the ability to perform instrumental activities of daily living in people with mild cognitive impairment (MCI) due to AD. This measure would be used to support labeling claims of new AD therapies.

Development of a Patient-Reported Outcome Instrument to Assess Complex Activities of Daily Living and Interpersonal Functioning in Persons with Mild Cognitive Impairment: The Qualitative Research Phase Patient Self-report for Evaluating Mild Cognitive Impairment and Prodromal Alzheimer’s Disease