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  • Print publication year: 2011
  • Online publication date: December 2011

16 - The use of MRI in multiple sclerosis clinical trials

from Section II - Clinical trial methodology

Summary

The Food and Drug Administration (FDA) has offered guidance on using health related quality of life (HRQoL) measures to support labeling claims, and the definition of HRQoL has become more systematized. HRQoL measures look at patients' reports of their perceived health in either very general or very particular terms. Utility assessment is an increasingly active area of research in multiple sclerosis (MS). HRQoL data are used for three general purposes: to classify or group patients by levels of disease severity, predict the health of subjects at a future point in time, and as outcome variables. MS-specific HRQoL measures have been included as endpoints in many clinical studies, including some randomized controlled clinical trials. Selection of the most appropriate disease-specific measures by investigators should be based on available validity and reliability data for those measures and the specific questions that the researcher hopes to answer.

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