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The Delayed-Start Study Design

List of authors.
  • Ralph B. D'Agostino, Sr., Ph.D.

Delayed-start study designs are a new way to distinguish a treatment's effects on long-term disease progression from its potential short-term effects on disease symptoms. In this article, the strengths, weaknesses, and key design assumptions of this type of trial are examined.

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Funding and Disclosures

Dr. D'Agostino reports being a special government employee of the Food and Drug Administration.

No other potential conflict of interest relevant to this article was reported.

Author Affiliations

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 .

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