Feeling the Pulse of Drug Development

XOMA (US) LLC develops Clinical Decision Support System with SAS^®

Perhaps the most visible aspect of biopharmaceutical development, clinical trials inherently generate massive amounts of data. For many pharmaceutical and biotechnology companies, the process of gathering and preparing that data into a final clinical study report (CSR) can take months or even years. At XOMA, however, access to clinical study data is automatic. Using SAS for Web-enabled reporting and analysis, researchers can view clinical trial data from their desktops, even while a trial is still ongoing.

Customer Success Video

Check out this video to learn more about XOMA and its successes with SAS.

View Video

• Windows Media Player
• Real Player

(Runtime: 3 mins, 27 secs)

---

Customer Viewpoint
You have questions; our customers have answers. Check out this video Q&A.

Nick Paszty
Manager of SAS Systems and Programming, XOMA Biostatistics Department

View Video

• Windows Media Player
• Real Player

---

(Requires Windows Media Player 6.4.7 or higher or RealPlayer 6 or higher)

Developing and manufacturing biopharmaceuticals that treat immunological and inflammatory disorders, cancer, and infectious disease, XOMA has a development pipeline that includes a number of different compounds in clinical trials and preclinical stages of testing, as well as others that are already available for licensing. XOMA's Clinical Decision Support System (CDSS), built with SAS/IntrNet, provides important safety and efficacy data about each of its ongoing clinical studies and also generates most of the content for the phase I CSR and most of the safety-related content for the phase II-III CSR.

Employees in medical affairs, regulatory affairs, clinical operations, drug safety, clinical data management, biostatistics and preclinical research access the system every day for the latest information about XOMA's ongoing studies. "SAS makes the process of their work more efficient," explains Nick Paszty, manager of SAS systems and programming at XOMA, "so the people that keep an eye on the studies are in the driver's seat."

Direct access to data
Using SAS business intelligence solutions, Paszty designed the Web-enabled system two years ago with one goal in mind: "To deliver the right information to the right people, the right way and at the right time." It's a mantra he lives by, saying, "To move ahead, we needed to really leverage SAS technology and especially SAS/IntrNet. We knew that if we could make this data available to key people for a larger percent of the life history of a study, it would be a big value-add for XOMA."

Paszty's system now gives researchers direct access to data during 75 percent of a trial's duration. In the past, he says, "researchers could review printed output at no more than a few predetermined time points." Additional data requests had to be manually requested and processed by data analysts who were already busy processing information for the CSR.

But things are different now. The new system automatically extracts and analyzes data from Oracle Clinical, presenting the results online and preparing data for the CSR. "SAS has helped me provide a solution to what I felt was the No. 1 challenge for XOMA: getting people in touch with the data, so they don't need to rely on others to get the information they need," says Paszty.

"This system has data touch points across the entire clinical data flow," he adds. "By providing online access to SAS data and to our Oracle databases, SAS really helps us keep a finger on the pulse of a study."

SAS encourages information sharing
Paszty's system supports more than 500 data requests every week, providing everything from simple site data to information from a study's complex statistical analysis plan. Access to each study starts with its home page where information on dosing, study type, contacts, database status, enrollment numbers and timing, and an interactive subject disposition hierarchy are available. Researchers can access the data from any of seven user-friendly areas whose data driven interfaces are authored dynamically.

These include:

• An ad hoc area where researchers request additional reports that can be rerun whenever new data becomes available.
• A safety area that includes standard reports on adverse events, concomitant medications, demographics, disposition, exposure, laboratory plots, vital signs summaries and more.
• A CSR area where users can access the study protocol, statistical analysis plan and a dynamic table of contents through which reports can be run.
• A sites area where patient enrollment reports are available, including drill-downs through maps to sites and patient-level data.
• A data review area that includes scanned case reports, data integrity and edit check reports, patient profile reports and a dynamic interface that allows nonprogrammers to run basic statistical analyses.

All users have permission to download data sets directly from the system for further analysis. Others, including the vice president of clinical and regulatory affairs, prefer the high-level view that shows the status of each research site and enrollment levels for each study.

Paszty says the system also has helped to encourage improved communication between departments. The preclinical research department, for example, used to work in isolation from the clinical trial teams, researching and testing new compounds for future studies. But now they can access clinical laboratory-level data that can help them better understand trends indicating how the compound might be working in the human body.

SAS tackles process improvements
Within his own unit, Paszty says SAS has freed up his analysts to develop new data-sharing ideas and to work on more advanced analyses. He says his biggest achievement has been developing a system that can create dynamic Web content while also providing static content for the clinical study report.

"SAS provides a huge benefit for dealing with our standard reporting issues, and it gives our programmers time to deal with more complex programming tasks and more important safety and efficacy issues instead," explains Paszty.

"SAS is powerful and easy to use," he adds, "And SAS/IntrNet is very cleverly developed. Given how much we've already accomplished, I foresee a strong partnership with SAS in the future."

Copyright © SAS Institute Inc. All Rights Reserved.