CDISC, FDA, Statistics and Networking: A Great Conference Idea

Contributed by Chris Decker, US Regional Director for PhUSE ~

PhUSE will be holding three Single Day Events between now and September 14 for pharmaceutical software users. PhUSE, (Pharmaceutical Users Software Exchange) began in 2005 in Europe to provide pharmaceutical software users with an environment where they could create and share ideas about tools, data standards and statistical and reporting technologies that support the clinical data flow. In 2006, PhUSE began holding an annual conference in Europe. Since, PhUSE has continued to build other communication and networking tools for users, including its single day events, technical journal, newsletter and Wiki (developed in collaboration with the FDA).

Although the organization was previously focused on Europe, there is now significant interest from US professionals, specifically US attendees to the European conference, CDISC staff and FDA representatives eager to find an outlet for communicating with the industry. Last fall, PhUSE held a Single Day Event in Cambridge, Massachusetts, a hotbed of biotechnology companies, to gauge the interest of PhUSE in the US. The event focused on the implementation of clinical data standards and featured FDA statisticians Steve Wilson and Matt Soukup who discussed the FDA's need for better standards to support its analysis and reporting. In addition, an interactive panel discussed the challenges of implementing standards and a number of excellent real world standard implementation stories were presented.

In 2011, PhUSE is focused on delivering three Single Day Events in the US. Here's where you can find them:

August 11, Philadelphia, Pennsylvania, at Drexel University - focus on the use of metadata throughout the clinical data flow from collection to submission.

August 31, San Francisco, California, at Genentech - PhUSE and CDISC will collaborate to deliver around the theme of New Frontiers for Clinical Data, including the development and application of therapeutic specific standards, the science and challenges of biomarker analysis and the implementation of diagnostic data standards and analysis.

September 14, Raleigh, North Carolina, at NC State University – the event will include case studies around implementing standard analysis data (i.e. ADaM), reporting, integration and metadata to support the analysis of clinical data. Geoff Mann from SAS will present "Metadata Submission Guidelines for ADaM: Implementation in version 1 of define."

Following the model in Europe, each event will be FREE for PhUSE members. If you are not a PhUSE member you will be able to attend for a discounted rate of US$40 dollars and become a PhUSE member. Register by clicking the links above. Attendance will be limited to ensure an intimate environment for sharing and networking.

CDISC, FDA, Statistics and Networking: A Great Conference Idea was published on SAS Users.