The role of the minimum clinically important difference and its impact on designing a trial

Author:

Chuang-Stein Christy,Kirby Simon,Hirsch Ian,Atkinson Gary

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference24 articles.

1. Food and Drug Administration Guidance for Industry 2009 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

2. The concept of clinically meaningful difference in health-related quality-of-life research;Hays;Pharmacoeconomics,2000

3. Determining a minimum clinically important difference between treatments for a patient-reported outcome;Kirby;Journal of Biopharmaceutical Statistics,2010

4. ICH 1998 http://www.ich.org/LOB/media/MEDIA485.pdf

5. Burke L Developing ‘Well-defined & Reliable’ Outcome Measures for Clinical Trials' 2007

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