PMID- 30235520
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200103
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 47
IP  - 4
DP  - 2013 Jul
TI  - A Framework for Managing the Minimal Clinically Important Difference in Clinical 
      Trials.
PG  - 447-454
LID - 10.1177/2168479013487541 [doi]
AB  - There is a long history of discussions about what is a minimal clinically 
      important difference (MCID) and how this term applies to clinical research. This 
      paper deals with a practical framework for MCID and its applicability to clinical 
      trials. A literature review on the topic confirmed the fundamental role of MCID 
      for the clinical research, although no guide on how to best use the MCID in 
      clinical trials was identified. We propose a framework that takes into account 
      (1) the definition of MCID as a term when random variable is discussed, (2) a 
      4-level approach for classifying the MCID evidence to be considered in a clinical 
      development program, and (3) a method of MCID evaluation, defined in a 
      scientifically sound protocol. The proposed framework can prompt and steer 
      stakeholders to improve the methodological sense of clinical trials based on the 
      definition of MCID at the level of efficacy or safety, increase the quality of 
      data derived from clinical trials and reporting of results, and allow effective 
      planning of drug development programs.
FAU - Koynova, Denitsa
AU  - Koynova D
AD  - 1 Pharmaceutical professional, Dusseldorf, Germany.
FAU - Luhmann, Reinhold
AU  - Luhmann R
AD  - 2 Statistical consultant, Allensbach, Germany.
FAU - Fischer, Renate
AU  - Fischer R
AD  - 3 Clinical development professional, Heidelberg, Germany.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
OTO - NOTNLM
OT  - MCID
OT  - clinical relevance
OT  - clinical research
OT  - clinical trials
OT  - framework
EDAT- 2013/07/01 00:00
MHDA- 2013/07/01 00:01
CRDT- 2018/09/22 06:00
PHST- 2018/09/22 06:00 [entrez]
PHST- 2013/07/01 00:00 [pubmed]
PHST- 2013/07/01 00:01 [medline]
AID - 10.1177/2168479013487541 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2013 Jul;47(4):447-454. doi: 10.1177/2168479013487541.