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- Title
Non-linearity of Parkinson's disease progression: implications for sample size calculations in clinical trials.
- Authors
Guimaraes, Paulo; Kieburtz, Karl; Goetz, Christopher G; Elm, Jordan J; Palesch, Yuko Y; Huang, Peng; Ravina, Bernard; Tanner, Caroline M; Tilley, Barbara C
- Abstract
Estimation of sample size for long-term studies of neuroprotection in Parkinson's disease requires information on expected clinical decline. Values may be obtained by analyzing existing long-term data sets or by prediction models of clinical decline applied to available data from shorter-term trials. The most commonly used measure to track clinical decline is the Unified Parkinson's Disease Rating Scale (UPDRS) but this measure is also affected by symptomatic therapy. Models can help better understand behavior of the UPDRS after initiation of symptomatic therapy when scores will improve and eventually start deteriorating again.
- Publication
Clinical trials (London, England), 2005, Vol 2, Issue 6, p509
- ISSN
1740-7745
- Publication type
Journal Article
- DOI
10.1191/1740774505cn125oa