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Statistics in Medicine
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Volume 361:1304-1306 September 24, 2009 Number 13
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The Delayed-Start Study Design
Ralph B. D'Agostino, Sr., Ph.D.

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 by Olanow, C. W.
-PubMed Citation
To advance our understanding of treatments for diseases that progress slowly but that are ultimately debilitating, such as Alzheimer's disease, Parkinson's disease, rheumatoid arthritis, and chronic obstructive pulmonary disease, it is essential to evaluate the disease-modifying effects of administered treatments. It is also essential to separate these effects from the short-term beneficial effects on symptoms that such treatments may provide. This separation of improvement in symptoms from a change in primary disease progression can be difficult.

One such approach is the delayed-start design (also called the randomized-start design).1 Although there has been regulatory support for this approach,2 there have been . . . [Full Text of this Article]


Source Information

From the Mathematics and Statistics Department, Boston University, Boston.

Address reprint requests to Dr. D'Agostino at the Mathematics and Statistics Department, Boston University, 111 Cummington St., Boston, MA 02215, or at ralph@bu.edu.




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