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East 6 - Frequently Asked Questions

 

Resources Available for learning East 6.5

How do I access the East user manual and tutorials?

The East 6 User Manual and Tutorials can be accessed through Home -> Help-> User Manual / Tutorial. The manuals are PDF files, so you'll need Adobe Reader installed on your computer to read them. We can provide a printed copy of the manuals by sending a request to support@cytel.com.

How do I access East design-level help?

Design-level help appears in the right-side Help panel whenever a design is invoked.

We can also see this help from any other window by clicking the ‘?’ icon in the top-right corner of the input window.

The Help panel displays the control-specific text as well. Click on any input control and you'll see the Help panel updated with a short description, acceptable range and input options.

Cytel YouTube Channel

This channel provides access to talks by Cytel speakers as well as industry-recognized statisticians and leaders. See https://www.youtube.com/user/CytelVideos/videos

Cytel Blogs

Read Cytel's blog for interesting updates from Cytel and the clinical research industry.
See http://www.cytel.com/blog

Where can I find out about product updates?

For each released version, we create a webinar which explains the method and application of new additions in the latest version of East. Please visit https://www.cytel.com/east-6.5-video-replay.

Citation

How should we cite East software in our documentation?

"East 6 (2020). Statistical software for the design, simulation and monitoring clinical trials.
Cytel Inc., Cambridge MA."

Licensing and Installation of East 6

Do I need administrative privileges to install East 6?

Yes, you need Administrative privileges to install and update an East 6 license using the 'Update License' utility.

What are the minimum system requirements of East 6?

Hardware

CPU – 1 gigahertz (GHz) or faster x86 (32 bit) or x64 (64 bit) processor

Memory – 4 GB of RAM

Hard Drive – 5 GB of free hard disk space

Display – 1200 x 800 or higher resolution

Operating Systems

For the standalone version:

  • Windows 7
  • Windows 8
  • Windows 8.1
  • Windows 10
  • English, European and Japanese versions of Windows.

For the concurrent user version:

  • Windows Server 7
  • Windows 8
  • Windows 8.1
  • Windows 10
  • English, European and Japanese versions of Windows
  • Windows Server 2008
  • Windows Server 2012
  • Citrix
    • XenApp 6.0 on Windows 2008
    • XenApp 6.5 on Windows 2008
    • XenApp 7.6 on Windows 2008
    • XenApp 7.6 on Windows 2012

 

Does East 6 work on virtual machines?

By default, the standalone version of East 6 is not supported on virtual machines. However, we can create VM supported licenses on an as-needed basis.

 

The network version (East 6 clients) should work on virtual machines.

 

Is East 6 supported on Apple machines?

East 6 is not natively supported on Apple machines and requires a virtualization product like Parallels. Please see above for information on running East in a virtual environment.

 

Does the East Network licensing have any logging capabilities?

Yes, please email support@cytel.com for information regarding logging capability.

 

How to apply the license or update it using the utility?

You will receive the East 6 license in a file named 'lservrc' from Cytel. Save this file on your local directory. Go to the Start->All Programs menu of the computer. Right click on the 'Update License' utility under Cytel Architect-> East 6.x and 'Run it as Administrator'.

Select the license file using the Browse button and click 'Install'. The installed modules can be seen in the lower window of 'Upgrade Log'. You can now restart East 6 for the new license to take effect.

 

I am receiving a "Requested License Not Available" notice when I try to access certain features. What does this mean?

East 6 is a modular product, so to access features in a certain module, you must have other required modules as well. For example, to access features in East ADAPT, you will also need licenses for East SEQUENTIAL and East BASE. Contact support@cytel.com for any questions on licensing.

 

Can you provide us the information on installation and operational validation of East software?

Please note that before we release the software to clients, our quality control team carries out extensive manual as well as automated testing. To ensure the consistency of results from old and new versions, regression testing on all the features of the software is done as well. But the test cases used here are for internal use only.

For our customers, we provide the Installation and Operational Verification programs (IV/OV) along with the software. They are available under Start->All Programs->Cytel Architect

Running these programs creates log files. These programs are widely used by our clients and ensure adequate testing before actual deployment of the software.

 IQ (Installation Verification) script

This script verifies whether the software is completely and correctly installed by checking whether all the software components, XML and DLL files are in place.

 OQ (Operational Qualification) script

This script runs some representative test cases covering all the major modules/features of East and compares the runtime results to the benchmarks (benchmarks are validated results stored internally in the OV program). This ensures the quality and consistency of the results in the new version.

 

More details on the two scripts are available in Section 2.4 on Installation Verification and Operational Verification of the East 6.5 user manual. (Home->Help->User Manual)

Manual Examples

In addition to the IV and OV scripted testing, you can refer to the user manual and reproduce the results for some representative examples and modules.

You may want to find out from your statisticians about their favorite features and modules and run those examples first. The flow of examples is easy to follow.

Some examples in the manual require additional files (datasets) which are available to you in the Samples folder.

Validation Chapter

We do have a dedicated chapter to describe how every single feature was validated.
Please refer to the appendix chapter V on "Validating East Software". This covers validation strategies for all the features available in East 6.5.

 

Are Cytel software products 21 CFR compliant?

All Cytel software products are tested by various methods like comparison with other marketed software, published results etc.

A summary of these testing procedures is given in the appendix of the user manual of each of our software products.

Additionally, our software products come with installation verification scripts. After installing the software, you can run the scripts to confirm whether the software installation process has been successful or not and whether the software runs as described in the manual. Performance qualification (PQ) or "validation" can only be performed by end users testing for expected outcomes with their own scenarios and their own standard operating procedures.

 

How do I obtain my license key?

Please send an email to Support@cytel.com.

 

What kind of technical support options are available?

Questions are answered by a member of our support team of statisticians, IT and sales. We will answer your telephone questions between 9 a.m. and 5 p.m. EST. You can also email your questions to support@cytel.com. We generally answer email queries within a few hours.

Our support team can:

  • Suggest the appropriate product or procedure for the functionality required.
  • Answer questions about specific details of procedures, such as discussing features, options, and limitations.
  • Provide guidance during Cytel software installation and licensing matters.
  • Arrange upgrades to the most recent releases of Cytel software.

Queries related to R Integration

 

How do I integrate R with East?

R can be integrated with East 6 to run simulations by writing your own R functions. Refer to the Appendix on "R Functions" of the East 6 User Manual for more details on syntax and to the "Tutorial: Survival Endpoint" for a worked out example.

Please note that R software is not a part of East 6. You need to install it separately.

Once R is installed on the machine, connect it to the East 6 system by providing the path of the R installation directory in Home->Options->Global Settings->General.

Once this is done, please verify in the log window where you will find the R version connected to East 6.

What versions of R are compatible with East 6?

East 6.4 and later is compatible with R versions 2.9.0 to 3.5.1. East may or may not work well with later versions of R.

Is R a requirement to run East 6?

No, R integration is completely optional.

If R is not installed, the ability to include custom R functions to modify specific simulation steps will not be available. R integration is required only to integrate custom R functions with East and doesn't affect any of the core functionality of East.

 

 

Statistical Capabilities/Tips

 

 

How to access the adaptive features in East 6.

East 6 is sold in a modular format, which means that the features to which you have access depends on your licensing.

If you have license for BASE, SEQUENTIAL and ADAPT – You can use adaptive features for continuous and discrete endpoint tests. If you have BASE, SEQUENTIAL, SURVIVAL and SURVADAPT – You can use adaptive features for time-to-event or survival endpoint tests.

Please note that the adaptive features (CHW/CDL/MS Simulations, CHW IM and CP/MS Calculator) in East 6 are available for the following group sequential designs (no. of looks >=2):

  • Continuous-Two Samples-Difference of Means-Superiority
  • Discrete-Two Samples-Difference of Proportions-Superiority
  • Discrete-Two Samples-Ratio of Proportions-Superiority
  • Survival-Two Samples-Both Designs-Superiority

These features are available ONLY for:

  • 1 Sided Efficacy ONLY (H0 only) and
  • 1-Sided Efficacy-Futility (H0 or H1 (B/NB) trials.

Once you create a valid design, save the design row from the Output Preview area to Workbook (Library). This can be done by clicking the save icon. Now click ‘S’. The ‘Include Options’ list on right hand top should have SSR. Contact support@cytel.com for any further queries OR sales@cytel.com to help you with your licensing.

Once this is done, please verify in the log window where you will find the R version connected to East 6.

 

Why type 1 error is not getting preserved for unbalanced time to event design?

The reason that the simulations show a type-1 error inflation is that the critical boundary values of the design rely on the assumption of asymptotic normality and the independence of increments for the stage 1 and stage 2 statistics. These assumptions break down when the event rate is low and the randomization ratio is unequal.

The simulation module in EAST generates survival data in accordance with the exponential models specified so the simulation results are correct and the average power at termination for the low event rate, unequal randomization case is indeed inflated. The issue is that the critical values for declaring significance at the two looks rely on the standardized log-rank statistic converging to a normal distribution with mean 0 and variance 1. This convergence is much slower if there are very few events and the randomization is unbalanced.

Therefore it is always advisable to verify the analytical results by simulation. If the simulation results display a type-1 error inflation we advise to design the study with smaller nominal alpha, say alpha = 0.02, so that the actual type-1 error demonstrated under simulation will be less than 0.025.

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