East 4 (version 4.0.1, Maintenance Release)

					ReadMe Notes	
									January 25, 2006


	In this maintenance release, We have made East 4 software more robust by fixing 
	all the known bugs and 	several small problems. A list of bugs/problems that have 
	been fixed is in the attached pdf file. 

	In addition to this, the following special points can be noted:
	
	1. Now it will be possible to select and print multiple plans to appear side by 
	side on the same page.
	
	2. The bugs relating to non-English locale settings have been fixed.
	
	3. The Adjusted inference results algorithm in the IM sheet have been improved 
	causing small differences in the results of 4.0 and 4.0.1 versions.

	4. As a result of fixing the bugs, in situations where such fixing has taken place, 
	there would be differences between the results obtained in version 4.0 and the 
	current maintenance release version 4.0.1. For the same reason,there could be 
	differences in the results shown in, both the print and online manuals, and 
	the results obtained in the current maintenance release version 4.0.1. In all 
	the cases, we confirm that the results you get from the current release version are 
	the correct ones.

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                                     East 4 (Version 4.0)
							
					ReadMe Notes
									August 1, 2005

	EAST,the most popular software system to design, simulate and monitor clinical 
	trials is now better than ever, with powerful, expanded capabilities that have 
	been incorporated in the latest version that is in your hands - East 4. 
	------------------------
	What is new in East 4.0
	------------------------
	The new features added in East 4 include:
	* 26 New Designs
	* New Designs Coverage - One Sample, Paired Sample, Two Samples, K Samples and 
	  Regression
	* 9 New Normal End Point Designs - Superiority-One Sample (2), 
	  Superiority-Regression (3), and 
	  Equivalence-Two Samples (independent and crossover) (4)
	* 12 New Binomial End Point Designs-Superiority-One Sample (2), 
	  Superiority-Two Samples (4), Superiority-K Samples (1), 
	  Superiority-Regression (1), Non-inferiority (3), and 
	  Equivalence-Two Samples (1)
	* New Class of Studies for Ordinal End Point– Non-Parametric Studies 
	* Asymmetric Stopping  Boundaries
	* Generalized Non-inferiority designs
	* Design CI Charts (interactive)– Study the interrelationship between 
	  sample size, effect size and confidence limits of effect size at 
	  the design stage
	* Context Sensitive Help – Get help where and when you need it
	* Power vs Sample Size Charts
	* Scientific Calculator

	Two separate new modules are available in East 4 for those who wish to expand 
	on East’s already extensive capabilities for designing, simulating and 
	monitoring time-to-event and adaptive trials:

	EastSurv:Generalized Survival Studies: This module allows users to design, 
	simulate and monitor superiority and noninferiority group sequential trials for 
	time-to-event endpoints in which the patient enrollment is non-uniform, 
	the hazard rates of the treatment arms change over time, and patients drop out 
	at different rates on the two treatment arms. 
	
	EastAdapt: Adaptive Trial Designs:This module enables users to design,monitor 
	and simulate adaptive designs in a data-dependent manner with flexibility to 
	change the sample size, spending function, number and spacing of interim looks 
	while preserving the type I error.

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	Other Notes
	-----------------------

	1. Default Number of Looks in design sheet: In East 3.1, this number was 5, 
	   whereas in East 4 this number is 1.

	2. Post-Hoc Power: Unlike in East 3.1, this value is computed at the end of 
	   the trial only if the information fraction attained is at least equal to 1.

	3. Expected Accrual under H0: In certain situations, there may be slight 
	   difference in the estimation of this quantity between East 3.1 and East 4, 
	   the latter being more accurate.

	4. Import East 3.1 File: East 4 has facility to import East 3.1 file design data.

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	For more information: 
	website: http://www.cytel.com
 	email:  sales@cytel.com, support@cytel.com
	Phone: 617-661-2011, Fax: 617-661-4405
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