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Stat Med 1994 Jul 15-30;13(13-14):1493-9

Conclusions. 2

O'Neill RT


I have been asked to take an overall view of the presentations in this `early stopping rules¿ workshop and to extract some messages from them. in attempting to meet the charge to summarize what i have heard and what i have concluded over the last two days, i will focus on the following issues: the underlying theme of the workshop concerns whether the statistical strategies proposed for monitoring trials are a help or a hindrance to the successful completion of clinical trials; how much of a problem is this and what should be done about it; whether the current diversity in practical operational aspects of data monitoring and analysis is responsible for some trials being stopped earlier than planned and thus should we begin to develop some consensus on `good practices and procedures¿ in this area; and finally to place this topic within the broader public health framework of clinical trials of treatments for any life-threatening disease, what are the regulatory impacts and consequences of early stopping, especially when decisions regarding the licensure and marketing of treatments depends upon results from monitored clinical trials that might be stopped early.

Category: Journal Article
DOI: 10.1002/sim.4780131327
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2012-12-24