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Activity Number:
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172
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304770 |
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Title:
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Examining the Extent and the Impact of Missing Data in Oncology Clinical Trials
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Author(s):
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Mark Rothmann*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Ave. , Silver Spring, MD, 20993,
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Keywords:
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Progression free survival ; Overall survival ; Loss-to-follow-up
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Abstract:
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According to the intent-to-treat principle, analyses should be based on the grouping of patients as they were randomized and all patients should be followed to the endpoint or the end of study. For an unbiased comparison with valid p-values, an intent-to-treat analysis is essential. Increasingly in oncology, progression-free survival (PFS) is used as an endpoint to seek regular approval. It is difficult to have a meaningful intent-to-treat analysis of PFS. There have been registration studies having extensive loss-to-follow-up for PFS. When a toxic drug is added to a standard of care and PFS is not improved when compared with the standard of care alone, the type I error rate of the analysis is inflated due to the censoring that tends to be used. We will discuss the potential informativeness of censoring PFS due to loss to follow-up.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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