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Migrating to SAS 6.08 for Windows: the Merck CANDA Experience Frank S

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Migrating to SAS 6.08 for Windows: the Merck CANDA Experience Frank S Migrating to SAS 6.08 for Windows: The Merck CANDA Experience Frank S. Palmieri, Merck Research Laboratories Rob Rosen, Merck Research Laboratories Wanda Bidlack, Merck Research Laboratories Introduction ineluding a graphical user interface, database querying, In every industry there are computer applications that are graphing. statistical "analysis, document review features, critical for success. In the pharmaceutical industry, one file management utilities, and on-line help. In addition to such "critical success application" is known as a the migration, one of our objectives was to combine our Computer Assisted New Drug Application (CANDA). This existing CANDA features with those represented in is a tool designed to aid federal regulatory agencies in another CANDA system. The best features o~ both reviewing the effects of a drug before it is released to the systems remained and were placed on a common open market. As with any key system, performance and computing platform. We joined a statistical based CANDA, ease of use are important design considerations. Merck developed with SAS 6.07 on a RISC-based UHrix system, has created several CANDAs in the past six years, the and a medical based PC system that used Microsoft tools most recent o~ which involved migrating our latest CANDA for the document handling. Our goal was to create a from an Ultrix platform to a PC running Microsoft (MS) system with three primary features: a user friendly front­ Windows. end, a document review facility that depicts a visual duplicate o~ hard copy documents, and capabilities for Our new application is a large system based on MS Word querying data, creating graphics, and running statistical and the SAS 6.08 for Windows (Base, SCL, SAS/AF, analyses in a timely manner. SAS/FSP, SAS/GRAPH, and SAS/STAT). The system consists of approximately 400 catalog entries. A major The ultimate user of CANDA systems in the United States advantage of this migration was the opportunity to use is the Food and Drug Administration (FDA). FDA FRAME technology (ineluded in SAS 6.08 for Windows). requirements for CANDA features and response times are This product aids in the creation of a more "user friendly" of primary concern. Discussions with FDA reviewers Graphic User Interface (GUI). FRAME is SAS Institute's about performance yielded the following response time implementation of an object·oriented development tool. It specifications: statistical analyses should take no longer allows the creation of screens with built-in mouse driven than 30 minutes to complete and simple queries should functionality and native Windows graphical objects such average no longer than 5 minutes to complete. Further, as push buttons, scroll bars, and list boxes. we determined that this CANDA system would contain large amounts of data and must support some robust We learned a great deal about PC configurations, MS statistical analysis programs. This emphasized the critical Windows, and SAS 6.08 for Windows as we accomplished need for quick system response time. this migration. Our first purpose in this paper is to review the entire migration project, briefly describing the many Initial Configuration Evaluation steps involved from inijial platform evaluation through final An extensive design evaluation was performed to application development on the selected platform. Our establish the appropriate hardware and software intent here is that you gain a basic understanding of the configuration for this new CANDA. The following six many tasks involved in a platform migration for a large networked elien!!server designs and stand alone models interactive system, and that the information we present were examined. (See Figure 1 for diagrams of the various can be used as a guideline to plan other platform configurations.) migrations of a large interactive SAS application. • X-station PClRISC - A PC with X-station software Our second purpose is to present in more detail the LANed to a RISC workstation with the SAS platform evaluation and selection process. Performance system, data processing, and text processing evaluation is always an important component 01 a project software. that migrates an application across platforms, but the • PC Client/RISC Server - A PC with the SAS effort required on our part to complete it was particularly system and text display software LANed to a large because of our attempt to push the PClWindows RISC workstation with the SAS system, data platform to its limits. Hence, we hope that by describing processing software and text files. our process and findings in more detail, we can provide • Text PClData RISC - A PC with X-station and you with useful data as you consider this new platform for text processing software LANed to a RISC your own SAS applications. workstation with the SAS system and data processing software. Background - Existing Applications • Standalone PC - A standalone PC with the SAS Drug information is usually evaluated by muHiple system, data processing, and text processing reviewers within each regulatory agency. These software. reviewers represent different disciplines such as • Standalone RISC - A standalone RISC medicine, statistics, pharmacology, toxicology, and workstation with the SAS system, data chemistry. At Merck, CANDAs are modified for different processing, and text processing software. types of reviews, but-have many common capabilities 451 • Medical PClStatistical RISC - A standalone PC based on the existing medical CANDA and a Drug related data is extracted from the current company standalone RISC workstation based on the database (Inquire), is manipulated using the SAS system, existing statistical CANDA. and is stored in SAS datasets. The SAS system is needed to run statistical analysis programs contained in the CANDA. Relational database packages were considered Figure 1: Diagrams of Possible CANDA for the CANDA data repository, but there were no Configurations packages on RISC or PC platforms that could access SAS datasets. One alternative would be to convert SAS X ....tation PCIRISC datasets to relational tables. This task, however, would require a major revalidation of output from the statistical X-traffic SAS I analysis programs. This resulted in the decision to leave Oota I CANDA data in SAS dataset format. ! Tm i I I The X-station software runs in the Microsoft Windows ~PC RiSe environment, but provides an X-windows interface to the PC Client/RISC Server RISC workstation. AHhough functionally equivalent to Microsoft Windows, X-windows has a somewhat different data "look and feel." In these models the CANDA application I SAS I SAS packets I I resides on a RISC workstation server in an Ultrix I I environment. I -T... I ~ """ Pathworks was evaluated for the Network Operating -PC RISC System (NOS) in the PC clientIRlSC server model. The Text PC/Data RISC FDA and other international regulatory agenCies use Pathworks in their LAN environments. Pathworks offers IX-station I X-traffic sAS the capability of creating a remote DOS partition on a 1 I. server. This partition may be assigned a DOS drive letter in the Pathworks setup allowing DOS software direct Da!a G 1 I access to files stored on the remote partition. Pathworks also handles file buffering; it will download portions of an PC RISC accessed file as needed. Text files from a DOS partition Standalone PC on the server can be directly accessed by the client through Microsoft Word. Data on the DOS partition can be accessed by the client through the SAS system (using I DaIa I librefs). However, the SAS system under the Ultrix [ffi]I Tm I operating system on the server cannot access the DOS partition's file structure; the partition appears as one file to PC Ultrix. Standalone RISC The SAS system on the server must have access to data for executing queries, analyses, and graph programs. I Oa!a I The SAS system on the client must also have access to data for representation of table names, variable names, Tm [ffi]I I and unique values for user selection. A solution is to RISC store only a list of table names, column names, and Medical PCIStatistical RISC unique values in a DOS partition on the server. Dynamic maintenance of this list, however, would degrade response time. Each time a new table was created, a program must be invoked on the server to recreate the I [)ala I I Tm I list. The regenerated list must then be downloaded to the I Tool I client, converted to a DOS format, and then uploaded to the DOS partition on the server. These problems led to a ~Medical mStatistical decision against using Pathworks for this CANDA. A second atternative is to use SAS/CONNECT software. The various configuration possibilHies led us to compare This is a SAS system package that provides access to user interfaces presented through X-station software (to a files, hardware resources, and SAS system software on RISC machine), native operating system GUI's, versions remote systems. It allows access to SAS datasets across of the SAS system (6.07 to 6.08), file storage methods, platforms and operating systems. However, and file access times between a local and networked SAS/CONNECT does not perform file buffering. It system. uploads or downloads an entire file when remote access 452 is requested. This would seriously degrade response time Although the standalone PC model passed the initial due to extremely large datasets contained in the CANDA evaluation, there were still some reservations concerning system. Furthermore, data access is not transparent to system response time. The design team decided that either the programmer or the user. Requests for remote benchmarking a prototype PC was necessary. Response data must be hard coded as "remote submrrs" from the time values from the original statistical CANDA and elient to the server. Also, during download from the requirements from the FDA reviewers were used as server, a data transfer "status window" will appear on the baseline criteria for acceptable performance levels.
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