East Procs

What is East Procs?

East Procs allows users to make the most of East's popular Interim Monitoring Panel. East Procs gives clinical trial designers the chance to design trials using the modern MCPMod method.

PROC EastMonitor

East PROCs are a new tool for SAS users, which allows developers to access the East Interim Monitoring Dashboard in an SAS interface. SAS users can now design and monitor sequential group trials and perform a new estimate of the sample size. East PROCresults are easy to import back into East for interactive decisions and simulations.

EastMonitor Features

• Perfect conversion to SAS
• East data management and reporting capabilities available in SAS (for example, audit trails)
• Test and inference adjusted for early stop due to efficacy and/or futility, as well as application of the method of re-estimating the sample size of Cui, Hung and Wang (1999)
• Import east PROC results back east to make interactive decisions and simulations.

East Procs

Since the Multiple Comparison Procedure Model (better known as the MCPMod method) has been approved by the FDA and EMA, its prevalence in the clinical trial project has increased.

East Procs allows dose determination test designers to consider the popular MCPMod method in their modern clinical trial projects.

East Procs: dosing determination for modern clinical trials

Switching to a Phase 3 study with correct doses no longer requires just getting the correct dose. While regulators expect first-line researchers to understand how new drugs work, sponsors have found that dose-response modeling is critical to lessening the risks of Phase 3 trials.

Adjusting the right model to your data can generate a lot of information about your processing. A good template provides information that you could easily lose. Finding this model also means that in case the doses tested in Phase 3 fail, sponsors don't have to go back and conduct more Phase 2 studies. An incorrect adjustment, however, can lead a test to an expensive path to failure.

The East Procs method was developed to test multiple dose-response models at once, using reliable multiple comparison procedures. Based on the works of Pinheiro, Bornkamp and Bretz (2006) and Bornkamp, Bretz, Dette and Pinheiro (2011), mcpmod's success depends on the flexibility to choose from a variety of candidate models and to protect sponsors from the costly consequences of incorrect specification of the model. It allows sponsors to test a wider dose range efficiently, providing enhanced data to get the dose selection right.

As vantagens do East Procs

Finally, you can access East Procs methods through your validated production environment, in compliance with standard operating procedures and good clinical practice. Why not let our market-leading team of software developers provide you with a validated PROC for use in SAS?

With the goal of providing flexibility, robustness and strong Family Wise Error Rate (FWER), East Procs offers the statistician judicious opportunities to navigate model uncertainty through quick comparations from various candidate models. Using a PROC to build your model means you can easily send rationalization to the chosen model along with other clinical data stored in the SAS.

Features in PROC MCPMod

• Create dose variation trials with a wide dose range by incorporating PROC MCPMod into your simulation program
• Evaluate a wide selection of candidate templates using an array of template shapes
• Protect against incorrect model specification
• Generate clear dialogue between statisticians and physicians on the nature of the dose-response curve
• Identify the minimum effective dose (MED) that is statistically significant and produces a relevant biological effect
• Get control of Family Wise Error Rate by using Multiple Comparison Procedures
• Analyze data using a variety of covariates and endpoints (e.g. continuous, binary, and count)
• Work with intuitive SAS syntax

East Procs allows you to perform various comparison and modeling procedures in Windows and UNIX environments on a variety of SAS platforms.

System requirements:

CPU: 1.8 GHz dual core processor

RAM: 2 GB

HDD / SSD: 50 GB of free space on the main drive

Operating system: Microsoft Windows 8 32-bit, Microsoft Windows 7 32-bit and Microsoft Windows Vista 32-bit

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