Clinical Outcome Assessments (COAs)

On October 19, 2011 the FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. OAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification  to establish that COAs are fit for purpose and appropriate for their context of use.

invivodata and our PRO Consulting division hosted a webinar on November 14 reviewing the highlights of the workshop. In this webinar, former FDA official Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty will review the key take-aways from the FDA workshop and discuss the implications to researchers using COAs in new medical product development.  Specific focus on choice and development of different types of outcomes will be reviewed, including the importance of content validity, reliability, construct validity and other measurement properties for all types of outcomes that are strategic to product development.

CLICK HERE TO REGISTER FOR WEBINAR REPLAY

Read “The Evidence for Endpoints:  PROs and Beyond”; Paty, J., Life Science Leader; January 2012

Summary:  In October 2011 FDA hosted a workshop that outlined their expectations for the development and qualification to establish that Outcome Assessments (OAs) – including Patient Reported Outcomess (PROs), Clinician Reported Outcomes (ClinROs), and Observer Reported Outcomes (ObsROs) – are fit for purpose and appropriate for their context of use. This article reviews the key take-aways of the workshop and its implications to researchers using OAs in new medical product development.

In addition to the webinar, complete the form below to read “The Evidence for Endpoints: PROs and Beyond.”