Why Reinvent the Wheel? Use or Modification of Existing Clinical Outcome Assessment Tools in Medical Product Development

Assessment of clinical benefit in treatment trials can be made through report by a clinician, a patient, or a nonclinician observer (eg, caregiver) or through a performance-based assessment. The US Food and Drug Administration (FDA) published a final guidance for industry for one type of clinical outcome assessment (COA) —patient-reported outcome (PRO) measures—in 2009 that described how FDA reviews PRO measures for their adequacy to support medical product–labeling claims. Many of the principles described in the PRO Guidance could be applicable to the other types of COAs, including instruments completed by cl inicians (ie, clinician-reported outcome assessments) and nonclinician observers (ie, observer-reported outcome assessments).
Source: Value in Health - Category: International Medicine & Public Health Authors: Source Type: research