2006D-0044
  

  
 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC15
  



  

  
Submitter : 
  

  
Dr. Stephen McKenna
  

  
Date & Time: 
  

  
04/14/2006 12:04:48
  



  

  
Organization : 
  

  
Galen Research
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Introduction



We are providing these comments from the perspective of disease-specific instrument developers with extensive experience in the field.



1. General Comments



The guidance outlined by the FDA is broadly welcomed as a means of encouraging scientists to raise the standards of PRO outcomes research. The guidance quite rightly asserts that any PRO used as an endpoint in a clinical trial should meet certain quality standards and these are presented largely in terms of psychometric quality (specifically, reliability, validity and interpretability). However, there are a number of fundamental omissions in the quality standards presented; most notably in relation to the theoretical basis of instruments and the fundamental measurement properties of the instruments. 



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006D-0044-EC15-Attach-1.DOC