PMID- 17136961
OWN - NLM
STAT- MEDLINE
DCOM- 20070222
LR  - 20191210
IS  - 1541-2555 (Print)
IS  - 1541-2563 (Linking)
VI  - 2
IP  - 1
DP  - 2005 Mar
TI  - U.S. regulatory perspective on the minimal clinically important difference in 
      chronic obstructive pulmonary disease.
PG  - 47-9
AB  - This paper outlines the regulatory issues surrounding the determination and use 
      of minimally clinically important differences (MCID) in assessing measures of 
      outcomes from treatments of chronic obstructive pulmonary disease (COPD). To 
      place this discussion in context, it is important to understand the current state 
      of approved therapies for COPD, as well as newer directions in therapy. This 
      paper discusses the currently available, approved drug therapies for COPD in the 
      United States and how they were approved. This is followed by an overview on the 
      use of MCID for assessing outcomes in therapies for COPD, as well the more 
      general experience with MCID from the U.S. regulatory perspective.
FAU - Meyer, Robert J
AU  - Meyer RJ
AD  - Office of Drug Evaluation II, Center for Drug Evaluation and Research, U.S. Food 
      and Drug Administration, Room 13B-28, HFD-102, 5600 Fishers Lane, Rockville, 
      Maryland 20857, USA. meyerro@cder.fda.gov
LA  - eng
PT  - Journal Article
PL  - England
TA  - COPD
JT  - COPD
JID - 101211769
SB  - IM
MH  - Clinical Trials as Topic
MH  - Data Interpretation, Statistical
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Outcome Assessment, Health Care/legislation & jurisprudence
MH  - Pulmonary Disease, Chronic Obstructive/physiopathology/*therapy
MH  - Treatment Outcome
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2006/12/02 09:00
MHDA- 2007/02/23 09:00
CRDT- 2006/12/02 09:00
PHST- 2006/12/02 09:00 [pubmed]
PHST- 2007/02/23 09:00 [medline]
PHST- 2006/12/02 09:00 [entrez]
AID - 10.1081/copd-200050660 [doi]
PST - ppublish
SO  - COPD. 2005 Mar;2(1):47-9. doi: 10.1081/copd-200050660.